Label: SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS- benzalkonium chloride liquid
- NDC Code(s): 35000-253-11
- 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 December 10, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 332 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-253 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) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM BENZOATE (UNII: OJ245FE5EU) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) SODIUM CHLORIDE (UNII: 451W47IQ8X) EDETATE SODIUM (UNII: MP1J8420LU) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-253-11 332 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 10/04/2022 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive Company 079342773 ANALYSIS(35000-253) , MANUFACTURE(35000-253) , PACK(35000-253) , LABEL(35000-253) Establishment Name Address ID/FEI Business Operations VeePak, Inc 874763303 MANUFACTURE(35000-253)