Label: ANTIBACTERIAL- benzalkonium chloride liquid
- NDC Code(s): 71020-001-16, 71020-001-20
- Packager: Sante Manufacturing Inc
- 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 17, 2022
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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:71020-001 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 GLYCERIN (UNII: PDC6A3C0OX) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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:71020-001-16 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2016 2 NDC:71020-001-20 600 mL in 1 BOTTLE; 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 - Sante Manufacturing Inc (242048747) Registrant - Sante Manufacturing Inc (242048747) Establishment Name Address ID/FEI Business Operations Sante Manufacturing Inc 204348627 manufacture(71020-001) Establishment Name Address ID/FEI Business Operations Brands International Corporation 243748238 manufacture(71020-001)