Label: ANTIBACTERIAL- benzalkonium chloride liquid
- NDC Code(s): 50157-003-32
- Packager: Brands International Corporation
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated May 25, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50157-003 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 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50157-003-32 947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/08/2016 Labeler - Brands International Corporation (243748238) Registrant - Sante Manufcaturing Inc (242048747) Establishment Name Address ID/FEI Business Operations Brands International Corporation 243748238 manufacture(50157-003)