55355-060 alcohol wipes

4
ALCOHOL WIPES- alcohol wipes cloth Wenzhou Mulan Paper Co., Ltd 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. ---------- 55355-060 ALCOHOL WIPES Active Ingredient(s) Alcohol 75% v/v. Purpose: Antiseptic Purpose Antiseptic,Alcohol wipes Use For cleaning and reducing germs and bacteria that could cause disease when soap & water are not available. Warnings For external use only. Flammable. Keep out of reach of children. Store away from directly sunlight. Avoid contact with eyes, open skin and other sensitive areas. In case of irritation, discontinue use. Do not use in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. Other information Place in a cool dry place. Avoid direct contact with sunlight. Inactive ingredients

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Page 1: 55355-060 ALCOHOL WIPES

ALCOHOL WIPES- alcohol wipes cloth Wenzhou Mulan Paper Co., LtdDisclaimer: 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.

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55355-060 ALCOHOL WIPES

Active Ingredient(s )Alcohol 75% v/v. Purpose: Antiseptic

PurposeAntiseptic,Alcohol wipes

UseFor cleaning and reducing germs and bacteria that could cause disease when soap & water are notavailable.

WarningsFor external use only. Flammable. Keep out of reach of children. Store away from directly sunlight.Avoid contact with eyes, open skin and other sensitive areas. In case of irritation, discontinue use.

Do not usein children less than 2 months of ageon open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyesthoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rightaway.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rightaway.

DirectionsPlace enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Other informationPlace in a cool dry place.Avoid direct contact with sunlight.

Inactive ingredients

Page 2: 55355-060 ALCOHOL WIPES

purified water USP

Package Label - Principal Display Panel

ALCOHOL WIPES alcohol wipes cloth

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:55355-0 6 0

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 3.8 mL

Page 3: 55355-060 ALCOHOL WIPES

Inactive IngredientsIngredient Name Strength

WATER (UNII: 0 59 QF0 KO0 R)

Product CharacteristicsColor Score

Shape Siz e

Flavor Imprint Code

Contains

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:55355-0 6 0 -0 1 6 0 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20

2 NDC:55355-0 6 0 -0 2 1 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20

3 NDC:55355-0 6 0 -0 3 10 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20

4 NDC:55355-0 6 0 -0 4 20 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20

5 NDC:55355-0 6 0 -0 5 30 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20

6 NDC:55355-0 6 0 -0 6 50 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20

7 NDC:55355-0 6 0 -0 7 8 0 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20

8 NDC:55355-0 6 0 -0 8 10 0 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20

Page 4: 55355-060 ALCOHOL WIPES

Wenzhou Mulan Paper Co., Ltd

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

OTC mo no graph no t fina l part333A 0 3/30 /20 20

Labeler - Wenzhou Mulan Paper Co., Ltd (554550431)

Registrant - Wenzhou Mulan Paper Co., Ltd (554550431)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

Wenzho u Mulan Paper Co ., Ltd 554550 431 manufacture(55355-0 6 0 )

Revised: 9/2020