Label: HAND SANITIZER- alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 78319-009-01 - Packager: Pafer Foods & Beverages, S. de R.L de C.V.
- 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 July 27, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78319-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) GLYCERIN (UNII: PDC6A3C0OX) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78319-009-01 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/2020 Labeler - Pafer Foods & Beverages, S. de R.L de C.V. (812764102) Registrant - Pafer Foods & Beverages, S. de R.L de C.V. (812764102) Establishment Name Address ID/FEI Business Operations Pafer Foods & Beverages, S. de R.L. de C.V. 812764102 pack(78319-009) , label(78319-009)