Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78814-6000-1, 78814-6000-2, 78814-6000-3 - Packager: FARMIRAL, S.A. DE C.V.
- Category: HUMAN OTC DRUG LABEL
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 10, 2020
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- Official Label (Printer Friendly)
- DOSAGE AND ADMINISTRATION
- INACTIVE INGREDIENTS
- INDICATIONS
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS AND PRECAUTIONS
- WARNING
- STOP USE
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78814-6000 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 GLYCERIN (UNII: PDC6A3C0OX) 0.025 mL in 1 mL TROLAMINE (UNII: 9O3K93S3TK) 0.01 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.205 mL in 1 mL METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 0.06 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78814-6000-1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2020 2 NDC:78814-6000-2 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2020 3 NDC:78814-6000-3 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/08/2020 Labeler - FARMIRAL, S.A. DE C.V. (951579167) Registrant - FARMIRAL, S.A. DE C.V. (951579167) Establishment Name Address ID/FEI Business Operations FARMIRAL, S.A. DE C.V. 951579167 manufacture(78814-6000)