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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63505-163
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 35.23 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2.34 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.013 mL  in 100 mL
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.007 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.410 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63505-163-0460 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/11/2009
Labeler - YVES ROCHER NORTH AMERICA INC (201908311)
Establishment
NameAddressID/FEIBusiness Operations
DELTA PHARMA INC200161730manufacture

Revised: 12/2009
Document Id: c1301bb1-b78b-4e01-8062-3022a5bc28a2
Set id: 724e0e43-71cc-4bc1-9414-7cabe66c6b06
Version: 2
Effective Time: 20091211
 
YVES ROCHER NORTH AMERICA INC