Label: ADVANCED HAND SANITIZER- alcohol gel
- NDC Code(s): 41190-370-16, 41190-370-34, 41190-370-45
- Packager: Wakefern Food Corp.
- 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 13, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
- principal display panel
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INGREDIENTS AND APPEARANCE
ADVANCED HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41190-370 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 water (UNII: 059QF0KO0R) GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER COPOLYMER TYPE b (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) SULISOBENZONE (UNII: 1W6L629B4K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41190-370-16 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/27/2015 2 NDC:41190-370-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/27/2015 3 NDC:41190-370-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/27/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/27/2015 Labeler - Wakefern Food Corp. (069722418) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41190-370) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41190-370)