Label: IN GOOD HANDS- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78501-3000-1, 78501-3000-2, 78501-3000-3 - 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 June 7, 2020
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- Official Label (Printer Friendly)
- DOSAGE AND ADMINISTRATION
- INACTIVE INGREDIENTS
- DIRECTIONS
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- WARNINGS AND PRECAUTIONS
- WARNINGS
- ACTIVE INGREDIENT
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
IN GOOD HANDS
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78501-3000 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 TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL in 1 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.2585 mL in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78501-3000-3 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2020 2 NDC:78501-3000-1 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2020 3 NDC:78501-3000-2 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/05/2020 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(78501-3000)