Label: ANTISEPTIC HAND GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 63505-163-04 - Packager: YVES ROCHER NORTH AMERICA INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 11, 2009
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- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
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- ASK DOCTOR
- PURPOSE
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INGREDIENTS AND APPEARANCE
ANTISEPTIC HAND GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63505-163 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:63505-163-04 60 mL in 1 BOTTLE 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 Business Operations DELTA PHARMA INC 200161730 manufacture
