Label: CAREONE AMBER ANTIBACTERIAL HAND- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-320-07, 41520-320-56 - Packager: American Sales Company
- 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 February 15, 2018
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- Active ingredient
- Uses
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Inactive ingredients
Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19040), Red 33 (CI 17200).
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INGREDIENTS AND APPEARANCE
CAREONE AMBER ANTIBACTERIAL HAND
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-320 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) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) GLYCERIN (UNII: PDC6A3C0OX) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCO MONOETHANOLAMIDE (UNII: C80684146D) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM SULFATE (UNII: 0YPR65R21J) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 40 (UNII: WZB9127XOA) 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:41520-320-56 1656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/14/2018 2 NDC:41520-320-07 222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/14/2018 Labeler - American Sales Company (809183973) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(41520-320)