water, sodium c14-16 olefin sulfonate, peg-8

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SKINPHARMACY ADVANCED ACNE THERAPY KIT- salicylic acid, benzoyl peroxide CVS Health Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- CLARIFYING DAILY CLEANSER with Polytrap Technology 4 FL OZ (118 mL) Drug Facts Active Ingredient 2% Salicylic Acid Purpose Acne Treatment Use For the management of acne Warnings For external use only Ask a doctor or pharmacist before use if you are Using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. When using this product Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. When using this product avoid contact with eyes. If this occurs, immediately flush with water. Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center right away. Directions Use morning and night. Apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside use sunscreen Inactive ingredients Water, Sodium C14-16 Olefin Sulfonate, Peg-8, Cocamidopropyl Betaine, Xanthan Gum, Lauryl ®

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Page 1: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

SKINPHARMACY ADVANCED ACNE THERAPY KIT- salicylic acid, benzoyl peroxide CVS HealthDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CLARIFYING DAILY CLEANSER with Polytrap Technology4 FL OZ (118 mL)

Drug Facts

Active Ingredient2% Salicylic Acid

PurposeAcne Treatment

UseFor the management of acne

WarningsFor external use only

Ask a doctor or pharmacis t before use if you areUsing other topical acne medications at the same time or immediately following use of this product.This may increase dryness or irritation of the skin. If this occurs, only one medication should be usedunless directed by a doctor.

When us ing this productSkin irritation and dryness are more likely to occur if you use another topical acne medication at thesame time. If irritation occurs, only use one topical acne medication at a time.When using this product avoid contact with eyes. If this occurs, immediately flush with water.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact PoisonControl Center right away.

DirectionsUse morning and night.Apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes.Rinse thoroughly with warm water.Pat dry.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.If going outs ide use sunscreen

Inactive ingredientsWater, Sodium C14-16 Olefin Sulfonate, Peg-8, Cocamidopropyl Betaine, Xanthan Gum, Lauryl

®

Page 2: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

Methacrylate/Glycol Dimethacrylate Crosspolymer, DMDM Hydantoin, Disodium EDTA, TocopherylAcetate, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Sodium BenzotriazolylButylphenol Sulfonate, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) RootExtract, Phenoxyethanol, Yellow 5, Red 40, Fragrance.

ACTIVE CLEARING LOTION with Microsponge Technology0.75 FL OZ (22 mL)

Drug Facts

Active IngredientBenzoyl Peroxide 2.5%

PurposeAcne Treatment

Usefor the management of acne

WarningsFor external use only

Do not use this medication if youHave very sensitive skinAre sensitive to benzoyl peroxide

When us ing this productAvoid unnecessary sun exposure and use a sunscreen after using this product.Avoid contact with lips, eyes, or mouth.If product gets into eyes rinse thoroughly with water.Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling.Irritation may be reduced by using the product less frequently or in lower concentration.Avoid contact with hair and dyed fabrics, which may be bleached by this product.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a PoisonControl Center right away.

DirectionsClean skin thoroughly before applying this product.Apply a thin layer to affected area one to two times per day.Because excessive drying of the skin may occur, start with one application daily, then graduallyincrease to two to three time daily if needed or as directed by a doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredientsWater, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cetyl Alcohol, Sorbitol,Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, Sodium

®

Page 3: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

Lauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, Propylparaben.

SPOT TREATMENT with Microsponge Technology0.4 FL OZ (12 mL)

Drug Facts

Active IngredientBenzoyl Peroxide 5%

PurposeAcne Treatment

Usefor the management of acne

WarningsFor external use only

Do not use this medication if youHave very sensitive skinAre sensitive to benzoyl peroxide

When us ing this productAvoid unnecessary sun exposure and use a sunscreen after using this product.Avoid contact with lips, eyes, or mouth.If product gets into eyes rinse thoroughly with water.Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling.Irritation may be reduced by using the product less frequently or in lower concentration.Avoid contact with hair and dyed fabrics, which may be bleached by this product.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a PoisonControl Center right away.

DirectionsClean skin thoroughly before applying this product.Cover the entire affected area with a thin layer one to three times daily.If going outside apply sunscreen after using this product and consult a physician. Keep tightlyclosed and avoid storing at extreme temperatures (below 40°F and above 100°F).

Inactive ingredientsWater, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sorbitol, Cetyl Alcohol,Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, SodiumLauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, Propylparaben.

Distributed by: CVS Pharmacy, Inc.One CVS Drive, Woonsocket, RI 02895

®

Page 4: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

© 2014 CVS/pharmacy

CVS.com 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components

V-31490

CVS QualityMoney Back Guarantee

#975032

M050779CP

Principal Display Panel - Carton LabelSKIN+PHARMACYADVANCEDACNE THERAPY KIT$35 VALUE

$19.99BONUS:Includes 2 Gentle FacialCleansing Sponges

exclusively atCVS/pharmacyONE MONTH SUPPLYActual Size Product Shown

®

®

Page 5: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

Principal Display Panel - Clarifying Daily Cleanser Tube LabelSKIN+PHARMACYADVANCEDACNETHERAPYCLARIFYINGDAILY CLEANSERwith Polytrap TechnologyMaximum Strength

2% Salicylic Acidremoves excess skin oilsunclogs poresoil-free formula

DERMATOLOGIST TESTED

exclusively atCVS/pharmacy

®

Page 6: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

4 FL OZ (118 mL)

Principal Display Panel - Active Clearing Lotion Tube LabelSKIN+PHARMACYADVANCEDACNETHERAPYACTIVE CLEARING LOTIONwith Microsponge Technology

clinically proven to kill acne-causing bacteriaclinically proven to effectively reduce inflammatory lesionssoothing, oil-free formulaunclogs poresfragrance free

DERMATOLOGIST TESTED

exclusively atCVS/pharmacy0.75 FL OZ (22 mL)

®

Page 7: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

Principal Display Panel - Spot Treatment Tube LabelSKIN+PHARMACYADVANCED

Page 8: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

ACNETHERAPYSPOT TREATMENTwith Microsponge Technology5% Benzoyl Peroxide

clinically proven to effectively reduce inflammatory lesionseffectively kills acne-causing bacteriahelps reduce irritationfragrance free

DERMATOLOGIST TESTED

exclusively atCVS/pharmacy0.4 FL OZ (12 mL)

®

Page 9: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

SKINPHARMACY ADVANCED ACNE THERAPY KIT salicylic acid, benzoyl peroxide kit

Page 10: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 9 8 42-0 8 2

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 9 8 42-0 8 2-0 1 1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct 10 /0 1/20 14

Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 1 TUBE 118 mL

Pa rt 2 1 TUBE 22 mL

Pa rt 3 1 TUBE 12 mL

Part 1 of 3

SKINPHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILYCLEANSER salicylic acid liquid

Product InformationRoute of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

sa licylic a c id (UNII: O414PZ4LPZ) (sa licylic ac id - UNII:O414PZ4LPZ) salicylic ac id 20 mg in 1 mL

Inactive IngredientsIngredient Name Strength

Wa ter (UNII: 0 59 QF0 KO0 R)

so dium C14 -16 o lefin sulfo na te (UNII: O9 W3D3YF5U)

po lyethylene g lyco l 4 0 0 0 (UNII: 4R4HFI6 D9 5)

co ca mido pro pyl beta ine (UNII: 5OCF3O11KX)

Xa ntha n g um (UNII: TTV12P4NEE)

DMDM Hyda nto in (UNII: BYR0 546 TOW)

edeta te diso dium (UNII: 7FLD9 1C8 6 K)

.a lpha .-to co phero l a ceta te , DL- (UNII: WR1WPI7EW8 )

Ha ma melis virg inia na flo wer wa ter (UNII: 222MYC9 QUV)

Butylene g lyco l (UNII: 3XUS8 5K0 RA)

Ca lendula O ffic ina lis flo wer (UNII: P0 M7O4Y7YD)

l ico rice (UNII: 6 1ZBX548 8 3)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Page 11: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

FD&C Yello w No . 5 (UNII: I753WB2F1M)

FD&C red no . 4 0 (UNII: WZB9 127XOA)

La uryl Metha cryla te /Glyco l Dimetha cryla te Cro sspo lymer (UNII: EX0 F4CZ6 6 H)

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 118 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part333D 10 /0 1/20 14

Part 2 of 3

SKINPHARMACY ADVANCED ACNE THERAPY ACTIVE CLEARING benzoyl peroxide lotion

Product InformationRoute of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

benzo yl pero xide (UNII: W9 WZN9 A0 GM) (benzo yl pero xide - UNII:W9 WZN9 A0 GM) benzo yl pero xide 25 mg in 1 mL

Inactive IngredientsIngredient Name Strength

wa ter (UNII: 0 59 QF0 KO0 R)

g lycerin (UNII: PDC6 A3C0 OX)

methyl metha cryla te /g lyco l dimetha cryla te cro sspo lymer (UNII: EG9 79 8 8 M5Q)

cetyl a lco ho l (UNII: 9 36 JST6 JCN)

so rbito l (UNII: 50 6 T6 0 A25R)

g lyceryl dila ura te (UNII: MFL3ZIE8 SK)

stea ryl a lco ho l (UNII: 2KR8 9 I4H1Y)

ma g nesium a luminum silica te (UNII: 6 M3P6 4V0 NC)

so dium citra te (UNII: 1Q73Q2JULR)

sil ico n dio xide (UNII: ETJ7Z6 XBU4)

so dium la uryl sulfa te (UNII: 36 8 GB5141J)

citric a c id mo no hydra te (UNII: 29 6 8 PHW8 QP)

methylpa ra ben (UNII: A2I8 C7HI9 T)

xa ntha n g um (UNII: TTV12P4NEE)

pro pylpa ra ben (UNII: Z8 IX2SC1OH)

Page 12: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 22 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part333D 10 /0 1/20 14

Part 3 of 3

SKINPHARMACY ADVANCED ACNE THERAPY SPOT TREATMENT benzoyl peroxide lotion

Product InformationRoute of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

benzo yl pero xide (UNII: W9 WZN9 A0 GM) (benzo yl pero xide - UNII:W9 WZN9 A0 GM) benzo yl pero xide 50 mg in 1 mL

Inactive IngredientsIngredient Name Strength

wa ter (UNII: 0 59 QF0 KO0 R)

g lycerin (UNII: PDC6 A3C0 OX)

methyl metha cryla te /g lyco l dimetha cryla te cro sspo lymer (UNII: EG9 79 8 8 M5Q)

cetyl a lco ho l (UNII: 9 36 JST6 JCN)

so rbito l (UNII: 50 6 T6 0 A25R)

g lyceryl dila ura te (UNII: MFL3ZIE8 SK)

stea ryl a lco ho l (UNII: 2KR8 9 I4H1Y)

ma g nesium a luminum silica te (UNII: 6 M3P6 4V0 NC)

so dium citra te (UNII: 1Q73Q2JULR)

sil ico n dio xide (UNII: ETJ7Z6 XBU4)

so dium la uryl sulfa te (UNII: 36 8 GB5141J)

citric a c id mo no hydra te (UNII: 29 6 8 PHW8 QP)

methylpa ra ben (UNII: A2I8 C7HI9 T)

xa ntha n g um (UNII: TTV12P4NEE)

pro pylpa ra ben (UNII: Z8 IX2SC1OH)

Packaging

Page 13: Water, Sodium C14-16 Olefin Sulfonate, Peg-8

CVS Health

# Item Code Package Description Marketing Start Date Marketing End Date1 12 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part333D 10 /0 1/20 14

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part333D 10 /0 1/20 14

Labeler - CVS Health (062312574)

Registrant - AMCOL Health & Beauty Solutions , Inc. DBA (872684803)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

AMCOL Health & Beauty So lutio ns,Inc . DBA 8 726 8 48 0 3 ANALYSIS(6 9 8 42-0 8 2) , MANUFACTURE(6 9 8 42-0 8 2) , LABEL(6 9 8 42-

0 8 2) , PACK(6 9 8 42-0 8 2)

Revised: 3/2017