PROTEX  BALANCE ANTIBACTERIAL HAND- triclocarban 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®
BALANCE

Drug Facts

Active ingredient

Triclocarban 0.15%

Purpose

Antibacterial

Use

helps eliminate germs 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

Inactive ingredients

water, sodium C14-16 olefin sulfonate, lauramide DEA, PPG-2 hydroxyethyl cocamide, cocamidopropyl betaine, laureth-7, sodium chloride, fragrance, DMDM hydantoin, citric acid, tetrasodium EDTA, polyquaternium-7, aloe barbadensis leaf juice, glycerin, hydrolyzed silk, FD&C yellow no. 5, D&C red no. 33.

Questions?

Call toll-free 1-800-443-0602

Distributed by:
COLGATE-PALMOLIVE COMPANY, Distr.
Guaynabo, P.R. 00968-1705 Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label

FOR THE GOOD HEALTH OF YOUR SKIN

Protex®
BALANCE

Antibacterial Liquid Hand Soap
Daily Protection Against Germs

DERMATOLOGIST
TESTED

REFILL

128 FL OZ (1 GAL) 3.78 L

57201

Principal Display Panel - 3.78 L Bottle Label
PROTEX   BALANCE ANTIBACTERIAL HAND
triclocarban liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-850
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclocarban (UNII: BGG1Y1ED0Y) (Triclocarban - UNII:BGG1Y1ED0Y) Triclocarban1.5 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sodium C14-16 olefin sulfonate (UNII: O9W3D3YF5U)  
Lauric Diethanolamide (UNII: I29I2VHG38)  
Cocamidopropyl betaine (UNII: 5OCF3O11KX)  
Laureth-7 (UNII: Z95S6G8201)  
Sodium chloride (UNII: 451W47IQ8X)  
DMDM hydantoin (UNII: BYR0546TOW)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Edetate Sodium (UNII: MP1J8420LU)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Glycerin (UNII: PDC6A3C0OX)  
FD&C yellow no. 5 (UNII: I753WB2F1M)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorYELLOW (Yellow/Orange) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-850-19590 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/201112/31/2015
2NDC:35000-850-123780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/201112/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/10/201112/31/2015
Labeler - Colgate-Palmolive Company (068693167)

Revised: 8/2017
Document Id: 6a5cd299-5907-4926-abe0-f911e437f4df
Set id: a29f2d08-a7df-4296-aec5-f2217361a9a2
Version: 6
Effective Time: 20170807
 
Colgate-Palmolive Company