Label: BYOTROL HAND SANITIZER- benzalkonium chloride liquid
- NDC Code(s): 63002-002-12, 63002-002-50, 63002-002-75, 63002-002-99
- 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 December 14, 2017
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
BYOTROL HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63002-002 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 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) GLYCERETH-17 COCOATE (UNII: 3057VPT0KC) DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5) POLIHEXANIDE (UNII: 322U039GMF) CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL) C12-15 PARETH-7 (UNII: 3XY03A79QH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63002-002-99 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/02/2014 2 NDC:63002-002-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2014 3 NDC:63002-002-12 1250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2014 4 NDC:63002-002-75 9463 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/02/2014 Labeler - Advanced Hygienics LLC (065359009) Establishment Name Address ID/FEI Business Operations Wisconsin Pharmacal Company 800873986 manufacture(63002-002)