Label: SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS- benzalkonium chloride liquid liquid
- NDC Code(s): 35000-098-11
- Packager: Colgate-Palmolive 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 September 1, 2020
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- PRINCIPAL DISPLAY PANEL - 332 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS
benzalkonium chloride liquid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-098 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.33 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) GLYCERIN (UNII: PDC6A3C0OX) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) COCO MONOETHANOLAMIDE (UNII: C80684146D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-098-11 332 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 02/14/2020 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Veepak, Inc. 874763303 MANUFACTURE(35000-098) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive Company 079342773 ANALYSIS(35000-098) , MANUFACTURE(35000-098) , PACK(35000-098) , LABEL(35000-098)