Label: PROTEX BALANCE ANTIBACTERIAL HAND- benzalkonium chloride liquid
- NDC Code(s): 35000-255-75
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated December 10, 2019
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- SPL UNCLASSIFIED SECTION
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label
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INGREDIENTS AND APPEARANCE
PROTEX BALANCE ANTIBACTERIAL HAND
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-255 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 ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-255-75 221 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 10/17/2022 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive Company 079342773 ANALYSIS(35000-255) , MANUFACTURE(35000-255) , PACK(35000-255) , LABEL(35000-255) Establishment Name Address ID/FEI Business Operations VeePak, Inc 874763303 MANUFACTURE(35000-255)