Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78767-4001-2, 78767-4001-3, 78767-4001-4, 78767-4001-5 - Packager: SOLARNA, S.A. 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 June 5, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DIRECTIONS AND USAGE
- INACTIVE INGREDIENTS
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- WARNINGS AND PRECAUTIONS
- WARNINGS
- ACTIVE INGREDIENT
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DOSAGE AND ADMINISTRATION
Place enough product on hands to cover all surfaces. Rub hands together until dry
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
- HAND SANITIZER PACKAGE LABELS
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78767-4001 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 CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.2585 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78767-4001-2 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2020 2 NDC:78767-4001-3 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2020 3 NDC:78767-4001-4 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2020 4 NDC:78767-4001-5 4000 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 - SOLARNA, S.A. DE C.V. (951578903) Registrant - SOLARNA, S.A. DE C.V. (951578903) Establishment Name Address ID/FEI Business Operations SOLARNA, S.A. DE C.V. 951578903 manufacture(78767-4001)
