Label: HAND SANITIZER- ethyl alcohl liquid
- NDC Code(s): 37012-439-34
- Packager: Shopko Stores Operating Co., LLC
- 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 December 14, 2022
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- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-439 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 616 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SULISOBENZONE (UNII: 1W6L629B4K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-439-34 236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/02/2013 Labeler - Shopko Stores Operating Co., LLC (023252638) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37012-439) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37012-439)