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Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov ESTTA Tracking number: ESTTA1045565 Filing date: 03/28/2020 IN THE UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD Proceeding 91246051 Party Defendant Gems Style Inc. Correspondence Address JUAN DE LA CRUZ GEMS STYLE INC 6465 W 24TH AVE SUITE 201 HIALEAH, FL 33016 UNITED STATES [email protected] 305-305-1840 Submission Defendant's Notice of Reliance Filer's Name JUAN DE LA CRUZ Filer's email [email protected] Signature /JUAN DE LA CRUZ/ Date 03/28/2020 Attachments APPLICANT NOTICE OF RELIANCE-8-OPP.91246051.pdf(87900 bytes ) Exhibit A Notice of Reliance 8 Opp91246051.pdf(1538873 bytes ) Exhibit B Notice of Reliance 8 Opp91246051.pdf(342447 bytes ) Exhibit C Notice of Reliance 8 Opp91246051.pdf(1274857 bytes ) Exhibit C-1 Notice of Reliance 8 Opp91246051.pdf(699012 bytes ) Exhibit C-2 Notice of Reliance 8 Opp91246051.pdf(3761881 bytes ) Exhibit D Notice of Reliance 8 Opp91246051.pdf(580952 bytes ) Exhibit E Notice of Reliance 8 Opp91246051.pdf(144420 bytes ) Exhibit F Notice of Reliance 8 Opp91246051.pdf(408238 bytes )

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Page 1: ESTTA Tracking number: ESTTA1045565 03/28/2020ttabvue.uspto.gov/ttabvue/ttabvue-91246051-OPP-20.pdf · Botox injections was being sold in the United States market. Even Physicians

Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov

ESTTA Tracking number: ESTTA1045565

Filing date: 03/28/2020

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD

Proceeding 91246051

Party DefendantGems Style Inc.

CorrespondenceAddress

JUAN DE LA CRUZGEMS STYLE INC6465 W 24TH AVE SUITE 201HIALEAH, FL 33016UNITED [email protected]

Submission Defendant's Notice of Reliance

Filer's Name JUAN DE LA CRUZ

Filer's email [email protected]

Signature /JUAN DE LA CRUZ/

Date 03/28/2020

Attachments APPLICANT NOTICE OF RELIANCE-8-OPP.91246051.pdf(87900 bytes )Exhibit A Notice of Reliance 8 Opp91246051.pdf(1538873 bytes )Exhibit B Notice of Reliance 8 Opp91246051.pdf(342447 bytes )Exhibit C Notice of Reliance 8 Opp91246051.pdf(1274857 bytes )Exhibit C-1 Notice of Reliance 8 Opp91246051.pdf(699012 bytes )Exhibit C-2 Notice of Reliance 8 Opp91246051.pdf(3761881 bytes )Exhibit D Notice of Reliance 8 Opp91246051.pdf(580952 bytes )Exhibit E Notice of Reliance 8 Opp91246051.pdf(144420 bytes )Exhibit F Notice of Reliance 8 Opp91246051.pdf(408238 bytes )

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IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD

In the Matter of Application Serial No. 88/026,610 For the mark: BOTO SMARTPublished in the Official Gazette of December 25, 2018

ALLERGAN, INC., Opposer,

v. Opposition No. 91246051

GEMS STYLE INC., Applicant.

APPLICANT’S NOTICE OF RELIANCE PURSUANT TO RULE 2.122(e) and (g)

ON INTERNET MATERIAL

Applicant Gems Style, Inc., pursuant to Rule 2.122(e)(2) and (g) of the Trademark Rules of

Practice and Section 704.08(b) of the Trademark Trial and Appeal Board Manual of Procedure (June

2019), submits this Notice of Reliance on the internet materials attached as evidence. Specifically,

Applicant offers true and correct printouts of portions of the websites located at the following URL:

Exhibit A. http://ttabvue.uspto.gov/ttabvue/v?pno=91246051&pty=OPP&eno=7

Exhibit B. https://www.americanmedspa.org/news/169394/A-Black-Market-for-Botox.htm

Exhibit C-1. https://www.ebay.com/itm/163945074766

Exhibit C-2. https://www.google.com/search?

q=botox+injections+product&tbm=isch&chips=q:botox+injections+product,online_chips:allergan&hl=

en&ved=2ahUK…

Exhibit D.- https://www.medaestheticsgroup.com/botox-marketing

Exhibit E.- https://www.botoxcosmetic.com/

1

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In the above-listed website printout of portions of the TTAABVUE database accessible at

USPTO TTABVUE website (Exhibit A) with the Opposer's TESTIMONY DECLARATION OF

COLLEEN MCKENNA the Board can see, that this Opposer's Testimony is prove that Opposer’s

goods are "EXPENSIVE PRODUCT” and have "SOPHISTICATED PURCHASERS". Specifically, in

the point 25 where the Opposer says: “Because the BOTOX® Product is an injectable pharmaceutical

preparation, it may be injected by doctors (including primary care physicians, dermatologists, and

plastic surgeons) and dentists, as well as physician assistants and registered nurses. In some states,

licensed practical nurses, aestheticians, and medical assistants are authorized to inject the BOTOX®

Product under physician supervision. There is no standard, nationally-recognized certification or

accreditation for BOTOX® Product injections, but organizations such as the American Academy

of Facial Esthetics, the International Association for Physicians in Aesthetic Medicine, and The

American Association of Aesthetic Medicine and Surgery offer online and in-person training courses.”

In the above-listed websites printouts and throughout the Opposer's Testimony the Board

can appreciate that Opposer's goods have very high degree of care exercised by the purchasers and

ultimate user. The purchasers of Opposer's Marks are professional buyers. The prices of Opposer's

goods treatments are very expensive. The buyers of the Opposer's Marks are the Licensed Physicians at

the Licensed Aesthetic Clinic. It is impossible for the professionals listed by the Opposer at point 25 of

his Testimony to confuse a BOTOX Injection with a Hair Conditioner GS GEMS STYLE BOTO

SMART or vice versa as the Board can see in Exhibit C*, C-1 and C-2.

__________________________________

Exhibit C is the union of Exhibit C-1 and Exhibit C-2 both image in one page so that the two products , Applicant's mark and Opposer's

marks, can be seen comparatively side by side.

2

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The degree of care exercised by the purchasers of Opposer's Marks has been made even higher

since the warning made by the Foods and Drugs Adminitration (FDA) alerting the Physicians that Fake

Botox injections was being sold in the United States market. Even Physicians are prohibited from

purchasing Botox injections at pharmacies outside of the United States even if they are originals

Opposer Allergan, Inc. Products. "Buying fake Botox is clearly illegal since it is not FDA-approved,

but many physicians still ask- what if I buy the real thing but I purchase the Botox from a company

outside of the U.S- is that legal? The answer is no. It is true that Allergan sells Botox to pharmacies

outside the U.S., particularly Canada, for a much reduced price. Of course, it is very enticing for

physicians to buy the Botox on the cheap from a different country and ship it back to the U.S. However,

the U.S. Drug Enforcement Administration (DEA) makes it illegal to import Botox or any other

injectable from another country because the product cannot be properly monitored. Botox must be

purchased directly from Allergan in the US where the FDA maintains safety levels not so strictly

adhered to in other countries. Importation of cosmetic injectables like Botox from outside of the US

can be a felony, subject to one year in prison and $100,000 in fines.", as you can see in Exhibit B.

Therefore, Applicant respectfully established that there is not be likelihood of confusion

because this is a Consumer’s Degree of Care. The more sophisticated the potential buyers of the goods

or the more costly the goods, the more careful and discriminating the reasonably prudent purchaser

exercising ordinary caution may be. Where the ordinary consumer is deemed sufficiently

sophisticated to discern differences between two “competing marks”, the law forecloses protection for

the senior trademark. Highlighting here in favor of the applicant that according to the Opposer's

Testimony, Applicant's mark and Opposer's marks are not competing marks since the Opposer's

Testimony relates all the functions of Opposer's marks and none of them are related to hair care as the

3

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Applicant's mark does it. The point 4 of the Opposer's Testimony, titled BACKGROUND:

ALLERGAN AND THE BOTOX PRODUCT, says: "Allergan markets a portfolio of leading brands

and best-in-class products for the central nervous system, eyes care, medical aesthetics,

gastroenterology, women's health, urology, and anti-infective therapeutics." But specifically, the Board

can see that Opposer's marks do not take care of anything related to hair care. Therefore, Applicant

contends that Applicant's mark and Opposer's marks are not related.

CERTIFICATE OF SERVICE

I hereby certify that on March 28, 2020, I served the foregoing APPLICANT’S NOTICE OF

RELIANCE via e-mail to Opposer's addresses of record: [email protected],

[email protected], [email protected], [email protected],

[email protected], [email protected]

By: JUAN DE LA CRUZ, President

GEMS STYLE, INC.

6465 W 24TH AVE., SUITE 201

HIALEAH, FL 33016

[email protected]

Phone: 305-305-1840

4

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Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov

ESTTA Tracking number: ESTTA1031735

Filing date: 01/28/2020

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD

Proceeding 91246051

Party PlaintiffAllergan, Inc.

CorrespondenceAddress

KENNETH L WILTONSEYFARTH SHAW LLP2029 CENTURY PARK EAST, SUITE 3500LOS ANGELES, CA 90067UNITED [email protected], [email protected], [email protected], [email protected], [email protected],[email protected]

Submission Testimony For Plaintiff

Filer's Name Lauren M. Gregory

Filer's email [email protected], [email protected], [email protected]

Signature /Lauren M. Gregory/

Date 01/28/2020

Attachments McKenna Declaration BOTO.pdf(2782717 bytes )McKenna Ex A.pdf(2143550 bytes )McKenna Ex B.pdf(626464 bytes )McKenna Ex C.pdf(4364377 bytes )McKenna Ex D - Part 1.pdf(2970223 bytes )McKenna Ex D - Part 2.pdf(4298825 bytes )McKenna Ex E.pdf(461437 bytes )McKenna Ex F.pdf(596543 bytes )McKenna Ex G.pdf(2853891 bytes )McKenna Ex H.pdf(2420114 bytes )Cert of Svc - McKenna.pdf(4527 bytes )

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60925160v.3

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD

In the Matter of Application Serial No. 88/026,610 For the mark: BOTO SMART Published in the Official Gazette of December 25, 2018

ALLERGAN, INC.,

Opposer,

v.

GEMS STYLE INC.,

Applicant.

Opposition No. 91246051

TESTIMONY DECLARATION OF COLLEEN MCKENNA

I, Colleen McKenna, state as follows:

1. I am over the age of eighteen and am employed by Allergan, Inc. (“Allergan”) as

the Vice President of Marketing, Facial Aesthetics. The facts contained in this declaration are

known to me personally or are based on my review of documents created and kept in the

ordinary course of business, and if called as a witness, I could and would competently testify to

them.

2. I have worked in marketing for Allergan since 2006. I have held my current role

of Vice President of Marketing, Facial Aesthetics, since January 2015. In this role, I oversee the

domestic marketing programs for all of Allergan’s facial aesthetic products, including the

product sold under the registered trademark BOTOX® (the “BOTOX® Mark”).

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2 60925160v.3

I. BACKGROUND: ALLERGAN AND THE BOTOX® PRODUCT

3. Allergan, formed in 1977, is a global pharmaceutical company focused on

developing, manufacturing, and commercializing branded pharmaceuticals, devices, and biologic

products for patients around the world.

4. Allergan markets a portfolio of leading brands and best-in-class products for the

central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology,

and anti-infective therapeutics.

II. FDA APPROVALS OF THE BOTOX® PRODUCT

5. In or about 1988, Allergan acquired the rights to distribute a product called

“OCULINUM.” Having received approval from the United States Food and Drug Administration

(“FDA”) in 1989 for this product, Allergan began distributing the product, an injectable form of

botulinum toxin type A, under the BOTOX® Mark (the “BOTOX® Product”) at least as early as

1990. Since that time, Allergan has continuously marketed the BOTOX® Product under the

BOTOX® Mark.

6. The BOTOX® Product was initially approved for the treatment of blepharospasm

associated with dystonia in patients 12 years and older.

7. In addition to the indication listed in paragraph 6, as of October 2019, Allergan’s

BOTOX® Product is also FDA approved for the following therapeutic indications:

a. Treatment of overactive bladder (OAB) with symptoms of urge urinary

incontinence, urgency, and frequency, in adults who have an inadequate response

to or are intolerant of an anticholinergic medication;

b. Treatment of urinary incontinence due to destrusor overactivity associated with a

neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in

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3 60925160v.3

adults who have an inadequate response to or are intolerant of an anticholinergic

medication;

c. Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per

month with headache lasting 4 hours a day or longer)

d. Treatment of upper and lower limb spasticity in adult patients;

e. Treatment of upper limb spasticity in pediatric patients 2 to 17 years of age,

excluding spasticity covered by cerebral palsy;

f. Treatment of lower limb spasticity in pediatric patients 2 to 17 years of age,

excluding spasticity covered by cerebral palsy;

g. Treatment of cervical dystonia in adult patients, to reduce the severity of

abnormal head position and neck pain;

h. Treatment of severe axillary hyperhidrosis that is inadequately managed by

topical agents in adult patients; and

i. Treatment of strabismus in patients 12 years of age and older.

8. In or about 1999, Allergan began clinical trials of the BOTOX® Product for

cosmetic use and shipped the product under the BOTOX® Mark during those trials.

9. In April 2002, the FDA approved Allergan’s BOTOX® Product for a cosmetic

indication: the temporary improvement in the appearance of moderate to severe glabellar lines

associated with corrugator and/or procerus muscle activity—the wrinkles and lines commonly

referred to as frown lines.

10. In 2013, the FDA approved the BOTOX® Product for a second cosmetic

indication: the temporary improvement in the appearance of moderate to severe lateral canthal

lines associated orbicularis oculi activity—commonly known as “crow’s feet.”

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11. In 2017, the FDA approved the BOTOX® Product for a third cosmetic indication:

the temporary improvement in the appearance of moderate to severe forehead lines associated

with frontalis muscle activity. This approval rendered the BOTOX® Product the first and only

neurotoxin indicated for three facial treatment areas.

12. When the BOTOX® Product is used for its cosmetic indications, the FDA requires

that the term “Cosmetic” appear next to the BOTOX® Mark. Therefore, when Allergan promotes

the BOTOX® Product for a cosmetic indication, the mark appears as “BOTOX® Cosmetic.”

13. As of today, there are eleven FDA-approved therapeutic indications and three

FDA-approved cosmetic indications for the BOTOX® Product. Attached as Exhibit A is a true

and correct copy of the October 2019 version of the prescribing information for the BOTOX®

Product for therapeutic indications. Attached as Exhibit B is a true and correct copy of the

November 2019 version of the prescribing information for the BOTOX® Product for cosmetic

indications.

14. Clinical trials are frequently occurring to determine if Allergan’s BOTOX®

Product is effective for other indications, including hair loss. Attached hereto as Exhibit C are

true and correct printouts from ClinicalTrials.gov reflecting studies on use of Allergan’s

BOTOX® Product to treat hair loss.

III. ALLERGAN’S MARKETING OF ITS BOTOX PRODUCT

15. Shortly after the 2002 FDA approval of the BOTOX® Product to treat glabellar

lines, Allergan launched direct-to-consumer print, radio, television, and Internet advertising to

promote this new treatment option.

16. From 2002 through 2018, Allergan has invested more than $298 million in direct-

to-consumer advertising of the BOTOX® Product for its cosmetic indication.

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17. Since 2013, Allergan has spent on average nearly $200 million each year

marketing, advertising, and promoting its BOTOX® Product.

18. Attached hereto as Exhibit D are true and correct copies of samples of some of

Allergan’s print advertisements for its BOTOX® Product over the years. As shown, Allergan has

advertised its BOTOX® Product for cosmetic indications in popular and widely-circulated

magazines including Elle, Glamour, Self, Redbook, InStyle, and People. Allergan has also

marketed directly to health care professionals who administer the product in publications such as

Skin & Allergy News, Archives of Dermatology, and the Journal of the American Academy of

Dermatology.

19. Allergan promotes the BOTOX® Product online at, among other places, a website

located at www.botoxcosmetic.com, a true and correct printout of the home page of which is

attached as Exhibit E, and on various social media platforms. Allergan maintains a YouTube®

channel for BOTOX® Cosmetic and posts promotional content on Instagram® and Facebook®.

Allergan’s Instagram account for BOTOX® Cosmetic has 772,000 followers, as evidenced by the

true and correct printout attached as Exhibit F. Meanwhile, as of December 10, 2019, the

Facebook page for BOTOX® Cosmetic has been “liked” by 85,127 people, and has more than

87,000 followers, as evidenced by the true and correct printout attached as Exhibit G.

IV. CONSUMER AWARENESS OF ALLERGAN’S BOTOX® PRODUCT

20. In light of Allergan’s substantial and continuous marketing investment in its

BOTOX® Product, Allergan receives unsolicited placement for its BOTOX® Product thanks to

the product’s fame and popularity. For instance, in 2005, Brand Week magazine rated Allergan’s

BOTOX® Product as being the number one placed brand in television programs and movies,

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6 60925160v.3

notwithstanding the fact that Allergan has never paid to place its products in television or

movies.

21. In addition, the BOTOX® Product has received substantial nationwide media

attention. For example, the BOTOX® Product has twice appeared on the front page of the New

York Times, has appeared on the covers of Newsweek and People, and has been featured in every

major women’s beauty magazine. In fact, from 2002 to 2018, Allergan’s BOTOX® Product has

been advertised in more than 100 magazines, equating to more than 1,500 insertions. This figure

does not include the significant number of unsolicited mentions in organic beauty blogs

(personal websites) and vlogs (user-generated video coverage on sites like YouTube®) that cover

users’ experience with the BOTOX® Product. Because these are not paid placements, it is

difficult to quantify the number of mentions.

22. To inform its ongoing business development and marketing efforts, Allergan

conducts and obtains market research regarding its own products and competing products.

Allergan tracks the awareness of consumers at every range of the buying cycle—from consumers

who have never even considered using the BOTOX® Product or an injectable cosmetic

pharmaceutical, to those who are regular users.

23. Not surprisingly, as a result of Allergan’s extensive and continuous marketing

efforts and the huge success of the BOTOX® Product, as of November, 2019, the total unaided

brand awareness for the BOTOX® Product was 69% and the total aided brand awareness for the

BOTOX® Product was 95%. The universe for our awareness study consisted of aesthetically

oriented women, aged 30 to 65, who had never had any type of facial injectable before.

24. Through this market research, Allergan has also learned that other beauty

products, which consumers purchase with the hope of creating a more youthful or fresh

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7 60925160v.3

appearance, compete with Allergan’s BOTOX® Product even though the BOTOX® Product is an

injectable product and not a topically-applied product.

25. Because the BOTOX® Product is an injectable pharmaceutical preparation, it may

be injected by doctors (including primary care physicians, dermatologists, and plastic surgeons)

and dentists, as well as physician assistants and registered nurses. In some states, licensed

practical nurses, aestheticians, and medical assistants are authorized to inject the BOTOX®

Product under physician supervision. There is no standard, nationally-recognized certification or

accreditation for BOTOX® Product injections, but organizations such as the American Academy

of Facial Esthetics, the International Association for Physicians in Aesthetic Medicine, and The

American Association of Aesthetic Medicine and Surgery offer online and in-person training

courses.

26. As the BOTOX® Product has become increasingly popular, patients have sought

out injections not only at traditional doctors’ offices, but also at aesthetic medical centers and so-

called “med spas,” which offer both non-surgical aesthetic treatments and traditional day spa

services such as massage, skin care, and salon services for hair and nails. These med spas often

sell products that are used in, or complement, the cosmetic procedures and services they offer.

This includes both skin care products and hair products such as shampoo, conditioner,

straightener, and other styling aids.

27. Over the past several years, Allergan has noticed a trend in delivery of the

BOTOX® Product through aestheticians and med spas, where consumers are able to have all of

their beauty concerns addressed at a single location. Consumers who frequent these

establishments tend to have an interest in products and services that promote a more youthful and

aesthetically pleasing appearance, and are accustomed to seeing a single brand name associated

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8 60925160v.3

with a collection of beauty products to improve the appearance of hair and of skin (e.g., DOVE®

shampoo and DOVE® skin cream) for purchase at a single point of sale.

28. Indeed, it is common for both pharmaceutical preparations and cosmetics to be

sold in the same trade channels, namely, drug stores, pharmacies, and mass merchandisers and

supermarkets with pharmacy sections, as well as in med spas.

V. THE SUBSTANTIAL SALES OF ALLERGAN’S BOTOX® PRODUCT

29. Allergan’s BOTOX® Product has enjoyed nearly 30 years of commercial success.

During this time period, from 1998 through 2018, Allergan has earned revenues of more than

$28.7 billion for products sold under its BOTOX® mark, approximately 70% of which represents

U.S. sales. For the last five years, annual revenues for the BOTOX® Product averaged $2.75

billion annually, as shown in Allergan’s Annual Reports and Form 10-Ks, excerpts of which are

attached hereto as collective Exhibit H. The financial information in the Annual Reports and

Form 10-Ks include information regarding revenue for the years immediately preceding the year

of the report. For example, the 2002 Annual Report includes the amount of revenue Allergan

received from sales of the BOTOX® Product in 1998, 1999, 2000, 2001, and 2002. I therefore

have only included excerpts from eight of the Reports, which collectively reflect revenue figures

from 1998 through 2018. Allergan’s Annual Reports are prepared in the ordinary course of

business, and because Allergan is publicly traded, the financial information contained in those

reports is thoroughly audited each year. The table below provides an overview of Allergan’s

annual revenues for the BOTOX® Product from 1998 through 2018:

Year 1998 1999 2000 2001 2002 2003 2004 2005

Revenue

(millions)

$125.3 $175.8 $239.5 $309.5 $439.7 $563.9 $705.1 $830.9

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INDUSTRY NEWS: NEWS

A Black Market for Botox?Saturday, September 8, 2012   (0 Comments)

By Renee Elise Coover

Not only can you buy a fake Louis Vuitton handbag for $20 (normally priced over $1000) or acounterfeit iphone from China, but now you can even score fake Botox—a deadly toxin–on theBlack Market. Until now, Allergan, the only patented FDA-approved manufacturer of Botox in theUnited States, has successfully monopolized the market. Competition is on the rise as off-shoreand web-based companies lure licensed physicians to purchase counterfeit Botox at bargainprices by fraudulently claiming the Botox brand name on labels.

As Botox increasingly becomes more popular, claiming to cure not only wrinkles and frown linesbut even urinary incontinence and arthritis, the demand for this "miracle” drug is rapidlyincreasing. The demand continues to surge, and since there is no legitimate competitor, Allerganis able to use its monopoly power to increase the price.

As prices for this drug soar, illegitimate competition is surfacing – in the form of bootleg Botox.Physicians across the country are receiving mailers, emails and advertising materials fromdistributors claiming to sell Botox for much less than Allergan is charging and the question hasbecome- are these products legal? Can physicians purchase Botox from off-shore distributorsand how do they know if the distributor is selling "real” Botox or a counterfeit version?

According to the Food and Drug Administration (FDA), the United States Federal Food, Drug andCosmetic Act prohibits the interstate shipment (including importation) of unapproved newdrugs.[1] (http://www.americanmedspa.org/a-black-market-for-botox/#_ftn1) Thus, importing anydrug that lacks FDA approval—whether for personal use or otherwise—violates the law.

How does one know if the distributor’s Botox is an unapproved drug? The FDA states thatunapproved new drugs are "any drugs, including foreign-made versions of US-approved drugs,that have not been manufactured in accordance with and pursuant to FDA approval.”[2](http://www.americanmedspa.org/a-black-market-for-botox/#_ftn2) Any medicine bought overthe internet from foreign sources, from storefront businesses that offer to buy foreign medicinefor the physician, or during trips outside the United States, may not be safe or effective becausethese medicines present health risks and their safety cannot be FDA ensured.

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18/2/2020 A Black Market for Botox? - American Med Spa Association

https://www.americanmedspa.org/news/169394/A-Black-Market-for-Botox.htm 2/7

The distribution of this new bootleg Botox threatens to undermine the safe manufacture, saleand transport of a potentially dangerous – and even deadly – drug in the United States.Additionally, its distribution causes a huge risk malpractice for physicians. If a physicianpurchases bootleg Botox (knowingly or unknowingly), injects it into a patient, and the patient isinjured because the product has been contaminated or damaged in shipment, it is likely thephysician would be fully responsible.

The problem is not only affecting the U.S. market but is becoming widespread across the globe.Recently, in China, the public was warned by the Ministry of Public Security to ensure they arebuying real Botox after it was discovered that a Chinese company was selling locally-made fakeBotox.[3] (http://www.americanmedspa.org/a-black-market-for-botox/#_ftn3) The scam wasactually discovered after Allergan complained that its name, but not its product was being usedto sell Botox on an online shop in China.[4] (http://www.americanmedspa.org/a-black-market-for-botox/#_ftn4)

Buying fake Botox is clearly illegal since it is not FDA-approved, but many physicians still ask-what if I buy the real thing but I purchase the Botox from a company outside of the U.S- is thatlegal? The answer is no. It is true that Allergan sells Botox to pharmacies outside the U.S.,particularly Canada, for a much reduced price. Of course, it is very enticing for physicians to buythe Botox on the cheap from a different country and ship it back to the U.S. However, the U.S.Drug Enforcement Administration (DEA) makes it illegal to import Botox or any other injectablefrom another country because the product cannot be properly monitored.Botox must bepurchased directly from Allergan in the US where the FDA maintains safety levels not so strictlyadhered to in other countries. Importation of cosmetic injectables like Botox from outside of theUS can be a felony, subject to one year in prison and $100,000 in nes.[5](http://www.americanmedspa.org/a-black-market-for-botox/#_ftn5)

So as the instance of counterfeit and imported Botox escalates, physicians and other purchasersof this popular drug must take extra care to check their sources and avoid the allure of buyingBotox outside the U.S. on the cheap - because the results could be very expensive indeed.

__________________________________________________________________________________

Renee Elise Coover <[email protected] (mailto:[email protected])> practices withThiersch & Associates in Chicago, Illinois. Thiersch & Associates specializes in med spa law. Formore information contact Thiersch & Associates, 180 N. LaSalle St., Suite 3700, Chicago, Illinois60601, (312) 981-0990, [email protected] (mailto:[email protected]).

[1] (http://www.americanmedspa.org/a-black-market-for-botox/#_ftnref1)www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm(http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm)

[2] (http://www.americanmedspa.org/a-black-market-for-botox/#_ftnref2) Id.

[3] (http://www.americanmedspa.org/a-black-market-for-botox/#_ftnref3)http://www.globaltimes.cn/content/725765.shtml(http://www.globaltimes.cn/content/725765.shtml)

[4] (http://www.americanmedspa.org/a-black-market-for-botox/#_ftnref4) Id.

[5] (http://www.americanmedspa.org/a-black-market-for-botox/#_ftnref5)http://www.fda.gov/ICECI/CriminalInvestigations/(http://www.fda.gov/ICECI/CriminalInvestigations/)

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Page 40: ESTTA Tracking number: ESTTA1045565 03/28/2020ttabvue.uspto.gov/ttabvue/ttabvue-91246051-OPP-20.pdf · Botox injections was being sold in the United States market. Even Physicians

26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

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Marketing BOTOXYour un-of cial guide to generating more patients to your practice with Allergan's BOTOX.

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26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

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comprehensive guide on ”otox marketing. ”ookmark this page and return soon for

future updates)

During our consultations with physicians and med spa owners, we are often

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Cosmetic. BOTOX on its own is a highly sought-after treatment and can be a

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BOTOX  Marketingand Your  Practice.

The cornerstone of any ”OTOX marketing campaign should be the experience of

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26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

https://www.medaestheticsgroup.com/botox-marketing 3/11

digital and in-house marketing efforts.You can already start marketing with your

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26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

https://www.medaestheticsgroup.com/botox-marketing 4/11

Get BOTOX  PatientsRight Away with

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marketing BOTOX that there is. It needs to be done only by an

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nuances when running a BOTOX Google Campaign. It's every easy

to spend money without generating any requests for treatment

and encountered many practices that have not had success.

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Page 44: ESTTA Tracking number: ESTTA1045565 03/28/2020ttabvue.uspto.gov/ttabvue/ttabvue-91246051-OPP-20.pdf · Botox injections was being sold in the United States market. Even Physicians

26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

https://www.medaestheticsgroup.com/botox-marketing 5/11

Do you need to build your reputation and your clientele fast? While optimizing

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Do you need to build your reputation and your clientele fast? While optimizing

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Page 45: ESTTA Tracking number: ESTTA1045565 03/28/2020ttabvue.uspto.gov/ttabvue/ttabvue-91246051-OPP-20.pdf · Botox injections was being sold in the United States market. Even Physicians

26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

https://www.medaestheticsgroup.com/botox-marketing 6/11

right away.

Speak with a specialist that has experience running campaigns for aesthetics as it's

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Page 46: ESTTA Tracking number: ESTTA1045565 03/28/2020ttabvue.uspto.gov/ttabvue/ttabvue-91246051-OPP-20.pdf · Botox injections was being sold in the United States market. Even Physicians

26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

https://www.medaestheticsgroup.com/botox-marketing 7/11

Patient Outreach andEducating NewPatients about

BOTOX ( andaddressing any

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BOTOX.Schedule time with me

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26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

https://www.medaestheticsgroup.com/botox-marketing 8/11

While each aspect of ”OTOX marketing is important, the pieces of your marketing

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help your practice reach its true potential with us today to learn more about our

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Allergan has the BestBrand Box for

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effectiveness of ”OTOX. Their ”rand ”ox is a great place to start.

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26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

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feature support for their family of products. We highly recommend it for all of your

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glimpse at what your med spa is all about.However, whether you are a doctor, nurse

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Group we take the stress off of you and your business! Our marketing professionals

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26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

https://www.medaestheticsgroup.com/botox-marketing 10/11

Retain,Convert and

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26/2/2020 BOTOX Marketing for Your Practice | Five W ays to Market BOT OX.

https://www.medaestheticsgroup.com/botox-marketing 11/11

company that specializes in

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28/2/2020 Welcome to BOTOXCosmetic.com for Professionals! | BOT OX® Cosmetic

https://hcp.botoxcosmetic.com 1/2

REFERENCE:1. BOTOX Cosmetic Prescribing Information, October 2017.

BOTOX Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT: Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptomsconsistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing di culties. These symptomshave been reported hours to weeks after injection. Swallowing and breathing di culties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated forspasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. Inunapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lowerdoses.

Important InformationIndicationsBOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:- moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity- moderate to severe lateral canthal lines associated with orbicularis oculi activity- moderate to severe forehead lines associated with frontalis activity

IMPORTANT SAFETY INFORMATION (continued)CONTRAINDICATIONSBOTOX Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in theformulation.

THREE

INDICATIONS.

ONE NAME.

BOTOX Cosmetic is the only FDA-treatment for the temporary improthe appearance of moderate to seforehead lines, lateral canthal linesglabellar lines in adults.

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1

Actual patient treated for moderate to severe forehead, crow's feet and glabellar lines. Results may vary.

PRODUCT

Learn everything you need to know about BOTOX Cosmetic, including the results

from pivotal clinical studies.Actual patient treated for moderate to severe crow's feet

and glabellar lines. Results may vary.

®

DOSAGE & ADMINISTRATION

Find detailed instructions on how to correctly prepare and administer BOTOX Cosmetic.

.Actual patient treated for moderate to severe crow's feet

and glabellar lines. Results may vary.

®

IN YOUR PRACTICE

Unlock the full potential of your partnership with BOTOX Cosmetic with a range of

support services.Actual patient treated for moderate to severe forehead, crow's feet

and glabellar lines. Results may vary.

®

GETTING STARTED

Set up your new Allergan account and add BOTOX Cosmetic to

your practice.CREATE AN ACCOUNT

®

CONTACT US

Have questions about Allergan products, new accounts, payments, or orders?

Call Customer Service at 1-800-377-7790.GET IN TOUCH

®

®

®

®

®

BOTOX Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT: Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptomsconsistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing di culties. These symptomshave been reported hours to weeks after injection. Swallowing and breathing di culties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated forspasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. Inunapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and atlower doses.

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FULL PRESCRIBING INFORMATION INCLUDING BOXED WARNING WITH MEDICATION GUIDE

PRODUCT DOSAGE & ADMINISTRATION IN YOUR PRACTICE MORE INFO

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28/2/2020 Welcome to BOTOXCosmetic.com for Professionals! | BOT OX® Cosmetic

https://hcp.botoxcosmetic.com 2/2

WARNINGS AND PRECAUTIONSLack of Interchangeability between Botulinum Toxin ProductsThe potency Units of BOTOX Cosmetic are speci c to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biologicalactivity of BOTOX Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other speci c assay method.

Spread of Toxin EffectPlease refer to Boxed Warning for Distant Spread of Toxin Effect.No de nitiv e serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateralcanthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthallines, glabellar lines, and forehead lines) have been reported.

Serious Adverse Reactions With Unapproved UseSerious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOXinjections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX to the site of injection and/oradjacent structures. In several of the cases, patients had pre-existing dysphagia or other signi cant disabilities. There is insu cient information to identify factors associated with an increased risk for adversereactions associated with the unapproved uses of BOTOX . The safety and effectiveness of BOTOX for unapproved uses have not been established.

Hypersensitivity ReactionsSerious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection ofBOTOX Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, thecausal agent cannot be reliably determined.

Cardiovascular SystemThere have been reports following administration of BOTOX of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patientshad risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.

Increased Risk of Clinically Signi cant E ffects with Pre-existing Neuromuscular DisordersIndividuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when givenbotulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically signi cant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, andrespiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).

Dysphagia and Breathing Di cultiesTreatment with BOTOX and other botulinum toxin products can result in swallowing or breathing di culties. Patients with pre-existing swallowing or breathing di culties may be more susceptible to thesecomplications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).

Pre-existing Conditions at the Injection SiteCaution should be used when BOTOX Cosmetic treatment is used in the presence of in ammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Human Albumin and Transmission of Viral DiseasesThis product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variantCreutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. Nocases of transmission of viral diseases, CJD or vCJD have ever been identi ed for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONSThe most frequently reported adverse reaction following injection of BOTOX Cosmetic for glabellar lines was eyelid ptosis (3%).

The most frequently reported adverse reaction following injection of BOTOX Cosmetic for lateral canthal lines was eyelid edema (1%).

The most frequently reported adverse reactions following injection of BOTOX Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%) and eyelid ptosis (2%).

DRUG INTERACTIONSCo-administration of BOTOX Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxinmay be potentiated. Use of anticholinergic drugs after administration of BOTOX Cosmetic may potentiate systemic anticholinergic effects.

The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration ofanother botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX Cosmetic.

USE IN SPECIFIC POPULATIONSThere are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX Cosmetic in pregnant women. Ther e are no data on the presence of BOTOX Cosmeticin human or animal milk, the effects on the breastfed child, or the effects on milk production. 

Please see BOTOX Cosmetic Full Prescribing Information including Boxed Warning and Medication Guide.

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professional medical training.

BOTOX Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT: Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptomsconsistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing di culties. These symptomshave been reported hours to weeks after injection. Swallowing and breathing di culties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated forspasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. Inunapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and atlower doses.

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®

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10/3/2020 GS GEMS STYLE BOTO SMART Hair Treatment FormaldehydeFree-34oz /1000ml Kit x 4 | eBay

https://www.ebay .com/itm/164082673567 1/3

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Item specifics

Condition: New with box: A brand-new, unused, and unworn item(including handmade items) in the original packaging (such as... Read more

Gender: Unisex

Features: All Natural Ingredients, Contains Argan Oil, Contains Minerals,Contains Vitamins, Cruelty-free/No Animal T esting

Model: MEDIUM4

MPN: 4MEDIUM Country/Region of Manufacture: Dominican RepublicAge Group: All Ages Type: Brazilian Blowout/KeratinBrand: GS GEMS STYLE Hair Type: All Hair TypesUPC: Does not apply

Description

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10/3/2020 GS GEMS STYLE BOTO SMART Hair Treatment FormaldehydeFree-34oz /1000ml Kit x 4 | eBay

https://www.ebay .com/itm/164082673567 2/3

00069

PROFESSIONAL USE ONLY

GS GEMS STYLE BOTO SMART is a revolutionary hair reconstructor and volumen reducing treatmen that eliminates frizzy , leaving it healthy and shinny for about 4 months. It works on all type of hair .

INSTRUCTIONS:

1- Wash the hair with GS Gems StyleClarifying Shampoo 2 or 3 times and towel dry .

2- Divide hair into four quarter and apply GS GEMS STYLE Boto Smart to small sections from the root to the end. (If the hair has been treated witha lot of colors or relaxers, it could become stiff. In thatcase, comb the hair with a wet comb)

3- Let the treatment work for 20 to 45 minutes, then dry 100% and flat iron onsmall sections 430 gF, 4 to 6 times from the root to the end.

INGREDIENTS: AQUA, CETEARYL ALCOHOL, CETRIMONIUMCHLORIDE, STEARTRIMONIUM CHLORIDE, AMODIMETHICONEAND TRIDECETH-12, KERASOL, METHYL CHLOROISOTHIAZOLINONE, PHENOXYETHANOL, CITRIC ACID,BENZYL BENZOATE,AND METHYLISOTHIAZOLINONE, CI 16035, CI 17200, PARFUM

Distributed by Gems Style, Inc.www.gscosmetics.comMiami, FL 33016Made in Dominican Republic

GS GEMS STYLE BOTO SMART es un revolucionario reconstructor capilar y tratamiento reductor de volumen que elimina el encrespamiento,dejándolo saludable y brillante durante unos 4 meses. Funcionaen todo tipo de cabello.

INSTRUCCIONES:

1- Lava el cabello con GS Gems StyleChampú clarificador 2 o 3 veces y seque con una toalla.

2- Divide el cabello en cuatro cuartos y aplique GS GEMS STYLEBoto Smart a secciones pequeñas desde la raíz hasta el final. (Si el cabello ha sido tratado con muchos colores o desrizados, podría volverse rígido, en ese caso peine el cabello con un peine mojadoy)

3- Dejar el tratamiento trabajar durante 20 a 45 minutos, luego secar al 100% y planchar secciones pequeñas 430 gF , 4 a 6 veces desde la raíz hasta la punta.

More to explore : Thin Hair Hair Loss Treatments, WEN Conditioner Hair Care & Styling Sets & Kits, Dyson Hair Care & Styling Sets & Kits, MIZANI Hair Care & Styling Sets & Kits,CHI Hair Styling Sets/Kits, Cream Hair Care & Styling Sets & Kits, X-Fusion Hair Loss Treatments, Scalp Treatment Medicated Hair Treatments, WEN Unisex Hair Care & Styling Sets & KitRedken Unisex Set/Kit Hair Loss Treatments

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