Label: ALCOHOL FREE HAND SANITIZER- benzalkonium chloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 81685-321-10 - Packager: Hybrisan Ltd
- 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 March 7, 2021
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INGREDIENTS AND APPEARANCE
ALCOHOL FREE HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81685-321 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) 3A,4,5,6,7,7A-HEXAHYDRO-1H-4,7-METHANOINDEN-6-YL ACETATE (UNII: 5232EN3X2F) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) .ALPHA.-TERPINEOL (UNII: 21334LVV8W) LINALOOL, (+/-)- (UNII: D81QY6I88E) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) Product Characteristics Color yellow (Clear liquid) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81685-321-10 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/23/2021 Labeler - Hybrisan Ltd (219599200) Establishment Name Address ID/FEI Business Operations Hybrisan Ltd 219599200 manufacture(81685-321) Establishment Name Address ID/FEI Business Operations Gwalia Healthcare Limited 220632253 pack(81685-321)