Label: HAND SANITIZER- ethyl alcohol gel
- NDC Code(s): 0363-0596-16
- Packager: Walgreen Co
- 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 20, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
- Flammable
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Claims
- Adverse reactions section
- Principal display panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0596 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 63 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) glycerin (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SULISOBENZONE (UNII: 1W6L629B4K) MANNITOL (UNII: 3OWL53L36A) POWDERED CELLULOSE (UNII: SMD1X3XO9M) HYPROMELLOSES (UNII: 3NXW29V3WO) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) ULTRAMARINE BLUE (UNII: I39WR998BI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0596-16 59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/26/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/26/2015 Labeler - Walgreen Co (008965063) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(0363-0596) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(0363-0596)