NDC | 63002-004-33, 63002-004-50, 63002-004-99 |
Set ID | 1b225968-aff7-4959-89e1-a8edabb4d670 |
Category | HUMAN OTC DRUG LABEL |
Packager | Advanced Hygienics LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
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)