Label: FOAMING ADVANCED ANTIBACTERIAL HAND- benzalkonium chloride soap
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NDC Code(s):
50865-213-13,
50865-213-17,
50865-213-24,
50865-213-41, view more50865-213-50, 50865-213-52, 50865-213-78
- Packager: Kutol Products Company
- 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 18, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOAMING ADVANCED ANTIBACTERIAL HAND
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50865-213 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.003 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) PEG-6 COCAMIDE (UNII: YZ6NLA4O1E) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50865-213-24 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2015 06/20/2017 2 NDC:50865-213-41 1000 mL in 1 BAG; Type 0: Not a Combination Product 10/01/2015 3 NDC:50865-213-50 1200 mL in 1 BAG; Type 0: Not a Combination Product 10/01/2015 4 NDC:50865-213-78 950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2015 5 NDC:50865-213-13 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2015 6 NDC:50865-213-17 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2015 7 NDC:50865-213-52 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/01/2015 Labeler - Kutol Products Company (004236139) Registrant - Kutol Products Company (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products Company 004236139 manufacture(50865-213)