Label: FOAMING SANITIZING HAND- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 43196-683-09 - Packager: OPI Correctional Industries
- 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 January 20, 2016
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- 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 SANITIZING HAND
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43196-683 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43196-683-09 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/01/2015 Labeler - OPI Correctional Industries (809174501) Establishment Name Address ID/FEI Business Operations Kutol Products Company 004236139 manufacture(43196-683)