Label: ANTIBACTERIAL- benzalkonium chloride soap
- NDC Code(s): 69790-640-07, 69790-640-24, 69790-640-31
- Packager: Uline
- 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 August 24, 2023
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- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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- PURPOSE
- ACTIVE INGREDIENT
- WARNINGS
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69790-640 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 LAURAMINE OXIDE (UNII: 4F6FC4MI8W) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) GLYCERIN (UNII: PDC6A3C0OX) CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E) AMINO ACIDS, WHEAT (UNII: 0370GZL32F) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) WATER (UNII: 059QF0KO0R) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) D&C RED NO. 33 (UNII: 9DBA0SBB0L) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) Product Characteristics Color pink Score Shape Size Flavor CITRUS Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69790-640-07 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2017 2 NDC:69790-640-24 1000 mL in 1 BAG; Type 0: Not a Combination Product 09/12/2017 3 NDC:69790-640-31 1000 mL in 1 BAG; Type 0: Not a Combination Product 09/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/12/2017 Labeler - Uline (039612668) Registrant - Kutol Products Company (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products Company 004236139 manufacture(69790-640)
