PROTEX  ANTIBACTERIAL- triclosan cream 
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
CREAM

Drug Facts

Active ingredient

Triclosan 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, glycol stearate, cocamidopropyl betaine, sodium chloride, DMDM hydantoin, fragrance, polyquaternium-7, citric acid, tetrasodium EDTA, glycerin, hydrolyzed silk, aloe barbadensis leaf juice, FD&C red no. 40

Questions?

Call toll-free 1-800-443-0602

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

PRINCIPAL DISPLAY PANEL - 7.5 fl oz Bottle Label

PROTECTS THE GOOD HEALTH
OF YOUR SKIN

Protex®
CREAM

Antibacterial Liquid Hand Soap
With Extra Moisturizers

DERMATOLOGIST
TESTED

41764

7.5 FL OZ (221 mL)

PRINCIPAL DISPLAY PANEL - 7.5 fl oz Bottle Label
PROTEX   ANTIBACTERIAL
triclosan cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan1.5 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
Lauric Diethanolamide (UNII: I29I2VHG38)  
Glycol Stearate (UNII: 0324G66D0E)  
Cocamidopropyl betaine (UNII: 5OCF3O11KX)  
Sodium chloride (UNII: 451W47IQ8X)  
DMDM hydantoin (UNII: BYR0546TOW)  
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 MW) (UNII: 0L414VCS5Y)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Edetate Sodium (UNII: MP1J8420LU)  
Glycerin (UNII: PDC6A3C0OX)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
FD&C Red no. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-114-750.221 L in 1 BOTTLE; Type 0: Not a Combination Product12/09/200908/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E12/09/200908/31/2016
Labeler - Colgate Palmolive Company (068693167)

Revised: 12/2017
Document Id: 306b37de-595b-469f-bba2-87c8c8f78b53
Set id: a5a4812c-774e-40e2-9381-20e260e32fed
Version: 2
Effective Time: 20171205
 
Colgate Palmolive Company