Label: FOAMING ANTIBACTERIAL HAND WASH- 0.13% benzalkonium chloride soap
- NDC Code(s): 71303-213-31, 71303-213-41
- Packager: RJ Schinner
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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Drug Label Information
Updated August 24, 2023
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INGREDIENTS AND APPEARANCE
FOAMING ANTIBACTERIAL HAND WASH
0.13% benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71303-213 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.013 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) PEG-6 COCAMIDE (UNII: YZ6NLA4O1E) HC YELLOW NO. 5 (UNII: I844A312T7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71303-213-31 1000 mL in 1 BAG; Type 0: Not a Combination Product 03/30/2017 2 NDC:71303-213-41 1000 mL in 1 BAG; Type 0: Not a Combination Product 03/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/30/2017 Labeler - RJ Schinner (023432909) Registrant - Kutol Products, Inc. (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products, Inc. 004236139 manufacture(71303-213)