Label: HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 11344-989-06 - Packager: Vi-Jon
- 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 January 17, 2020
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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
- princpal display panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-989 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 545 mg in 1 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) CELLULOSE ACETATE (UNII: 3J2P07GVB6) HYPROMELLOSES (UNII: 3NXW29V3WO) ULTRAMARINE BLUE (UNII: I39WR998BI) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11344-989-06 32 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 10/08/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/08/2014 Labeler - Vi-Jon (150931459) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(11344-989)