Label: ANTIBACTERIAL- benzalkonium chloride 0.13% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 72308-016-01 - Packager: Flex Beauty Labs
- Category: HUMAN OTC DRUG LABEL
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 July 10, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- INDICATIONS & USAGE
- Warnings
- STOP USE
- When using this product
- Keep out of reach of children
- Directions
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
benzalkonium chloride 0.13% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72308-016 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) COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYSORBATE 20 (UNII: 7T1F30V5YH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) DMDM HYDANTOIN (UNII: BYR0546TOW) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72308-016-01 325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/10/2020 Labeler - Flex Beauty Labs (080858917)