Label: ANTIBACTERIAL 2X- benzalkonium chloride liquid
- NDC Code(s): 71020-016-16, 71020-016-20
- Packager: Sante Manufacturing Inc
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 17, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- WARNINGS
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANTIBACTERIAL 2X
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71020-016 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 WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) 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:71020-016-16 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/30/2018 2 NDC:71020-016-20 600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/30/2018 Labeler - Sante Manufacturing Inc (242048747) Registrant - Sante Manufacturing Inc (242048747) Establishment Name Address ID/FEI Business Operations Sante Manufacturing Inc 204348627 manufacture(71020-016) Establishment Name Address ID/FEI Business Operations Brands International Corporation 243748238 manufacture(71020-016)