Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77196-003-01 - Packager: Ignacio Reyes González
- 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 May 22, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DIRECTIONS OF DOSAGE AND ADMINISTRATION
- INACTIVE INGREDIENTS
- INDICATIONS AND USAGE
- KEEP OUT OF REACH OF CHILDREN
- ANTIMICROBIAL
- WARNINGS
- ACTIVE INGREDIENT
- HAND SANITIZER GEL PRINCIPAL DISPLAY LABEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77196-003 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 GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.2585 mL in 1 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77196-003-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/22/2020 Labeler - Ignacio Reyes González (951577216) Registrant - Ignacio Reyes González (951577216) Establishment Name Address ID/FEI Business Operations Ignacio Reyes González 951577216 manufacture(77196-003)
