Label: HAND SANITIZER- benzalkonium chloride solution
- NDC Code(s): 63002-004-33, 63002-004-50, 63002-004-99
- Packager: Advanced Hygienics 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 May 22, 2017
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63002-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLIHEXANIDE (UNII: 322U039GMF) CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL) C12-15 PARETH-7 (UNII: 3XY03A79QH) DIMETHICONE (UNII: 92RU3N3Y1O) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5) GLYCERETH-17 COCOATE (UNII: 3057VPT0KC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63002-004-33 9.76 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/18/2017 2 NDC:63002-004-99 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2017 3 NDC:63002-004-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/18/2017 Labeler - Advanced Hygienics LLC (065359009) Establishment Name Address ID/FEI Business Operations Wisconsin Pharmacal Company 800873986 manufacture(63002-004)