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Name:Antiseptic Hand Gel
Manufacturer:Yves Rocher North America Inc
Category:Over-the-counter (OTC) Marketed Drugs


ANTISEPTIC HAND GEL  - alcohol gel 
YVES ROCHER NORTH AMERICA INC

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.

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ANTISEPTIC HAND GEL

Eliminate 99.99% of germ

With Aloe Vera

60 ml   2 fl. oz.

ACTIVE INGREDIENT:

Ethyl alcohol 62%w/w

Keep out of reach of children. Children under 6 years of age must be supervised by an adult when using this product.

Avoid contact with eyes, should this occur rinse eyes thoroughly with water. If irritation occurs or increases discontinue the use immediately.

If irritation persists 2 or 3 days or swallowed consult a doctor

Antiseptic hand gel


ANTISEPTIC HAND GEL 
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63505-163
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER 35.23 mL  in 100 mL
GLYCERIN 2.34 mL  in 100 mL
ALOE VERA LEAF 0.013 mL  in 100 mL
ALPHA-TOCOPHEROL 0.007 mL  in 100 mL
CARBOMER 934 0.410 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63505-163-04 60 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 12/11/2009

Labeler - YVES ROCHER NORTH AMERICA INC (201908311)
Establishment
Name Address ID/FEI Operations
DELTA PHARMA INC 200161730 manufacture

Revised: 12/2009 YVES ROCHER NORTH AMERICA INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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