Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78501-1000-4, 78501-1000-5, 78501-1000-6, 78501-1000-7 - Packager: COMERCIAL GOURA,S. DE R.L.
- 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 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DIRECTION
- INACTIVE INGREDIENT SECTION
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INDICATIONS AND USAGE
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.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE SECTION
- WARNINGS AND PRECAUTIONS
- ACTIVE INGREDIENT
- ASK A DOCTOR
- ASK A DOCTOR
- STOP USE
- WARNING
- PACKAGE LABELS
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78501-1000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.2585 mL in 1 mL TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78501-1000-4 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/26/2020 2 NDC:78501-1000-5 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/26/2020 3 NDC:78501-1000-6 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/26/2020 4 NDC:78501-1000-7 4000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/26/2020 Labeler - COMERCIAL GOURA,S. DE R.L. (951578628) Registrant - COMERCIAL GOURA,S. DE R.L. (951578628) Establishment Name Address ID/FEI Business Operations COMERCIAL GOURA,S. DE R.L. 951578628 manufacture(78501-1000)
