PROTEX BALANCE ANTIBACTERIAL HAND- benzalkonium chloride liquid 
Colgate-Palmolive Company

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.

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Protex®

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

helps eliminate bacteria on hands

Warnings

For external use only

When using this product, avoid contact with eyes. In case of eye contact, flush with water.

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to hands, wash and rinse. Unique Formula. Refill only with Protex

Inactive ingredients

Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Citric Acid, Sodium Benzoate, PEG-120 Methyl Glucose Dioleate, Fragrance, Sodium Chloride, Tetrasodium EDTA, Yellow 5, Red 33.

Questions?

1-800-443-0602

Distributed by:
COLGATE-PALMOLIVE COMPANY, Distr.
Guaynabo, P.R. 00968-1705

PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

Eliminates 99.9% of Bacteria*

Protex®

For the Good Health of your Skin
Daily Protection Against Bacteria

BALANCE

DERMATOLOGIST
TESTED

Antibacterial Liquid Hand Soap

9904820
7.5 FL OZ (221 mL)

PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label
PROTEX BALANCE ANTIBACTERIAL HAND 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-255
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.33 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-255-75221 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E10/17/2022
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive Company079342773ANALYSIS(35000-255) , MANUFACTURE(35000-255) , PACK(35000-255) , LABEL(35000-255)
Establishment
NameAddressID/FEIBusiness Operations
VeePak, Inc874763303MANUFACTURE(35000-255)

Revised: 12/2019
Document Id: be239f80-c6df-4a9a-883d-2fc0c8a97268
Set id: d2514b67-303a-40f4-867b-9f41c0c8cba8
Version: 2
Effective Time: 20191210
 
Colgate-Palmolive Company