Label: HAND SANITIZER- alcohol gel
- NDC Code(s): 80711-002-01, 80711-002-02
- Packager: IVM Especialidades Quimicas, 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 February 14, 2023
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80711-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80711-002-01 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 2 NDC:80711-002-02 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/07/2021 Labeler - IVM Especialidades Quimicas, S.A. de C.V. (812761947) Establishment Name Address ID/FEI Business Operations IVM Especialidades Quimicas, S.A. de C.V. 812761947 manufacture(80711-002)