Label: ANTIBACTERIAL GOLD- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0116-3 - Packager: Kareway Product, 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 July 22, 2020
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- Active Ingredient
- Purpose
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- Directions
- Inactive Ingredient
- Package label
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL GOLD
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PALMITIC ACID (UNII: 2V16EO95H1) PEG-6 METHYL ETHER (UNII: WXH089JZ5E) PENTASODIUM PENTETATE (UNII: 961TOZ5L7T) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PALMITATE (UNII: JQ43KP6296) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) SORBITOL (UNII: 506T60A25R) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) WATER (UNII: 059QF0KO0R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0116-3 3 in 1 CELLO PACK 07/10/2020 1 100 g in 1 BOX; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/10/2020 Labeler - Kareway Product, Inc. (121840057)