Label: CLEANSE- benzalkonium chloride 0.13% solution
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NDC Code(s):
53329-177-04,
53329-177-06,
53329-177-08,
53329-177-25, view more53329-177-74, 53329-177-84
- Packager: Medline Industries, LP
- 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 August 9, 2023
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- Active ingredient
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- Warnings
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- Inactive ingredients
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- Package Label
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INGREDIENTS AND APPEARANCE
CLEANSE
benzalkonium chloride 0.13% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-177 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) SULISOBENZONE (UNII: 1W6L629B4K) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) EDETATE SODIUM (UNII: MP1J8420LU) GLYCERIN (UNII: PDC6A3C0OX) DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) WATER (UNII: 059QF0KO0R) MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-177-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2016 2 NDC:53329-177-08 221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2016 3 NDC:53329-177-84 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/19/2016 4 NDC:53329-177-25 3790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2016 5 NDC:53329-177-06 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2016 6 NDC:53329-177-74 1200 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/19/2016 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)