Label: HAND SANITIZER- ethyl alcohol gel
- NDC Code(s): 49035-712-21
- Packager: Wal-Mart Stores, Inc.,
- 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 5, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- uses
- Warnings
- flammable
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- claims
- Satisfaction guaranteed
- Adverse reaction
- principal display panel
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-712 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 620 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-712-21 88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/01/2018 Labeler - Wal-Mart Stores, Inc., (051957769) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(49035-712)