Protex® OATS

Drug Labeling and Warnings

Drug Details [pdf]

PROTEX OATS- 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®
OATS

Drug Facts

Active ingredient

Triclocarban 0.15%

Purpose

Antibacterial

Use

helps eliminate germs on hands

Warnings

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

wash hands and rinse

Inactive ingredients

water, sodium C14-16 olefin sulfonate, lauramide DEA, glycol stearate, PPG-2 hydroxyethyl cocamide, sodium chloride, cocamidopropyl betaine, laureth-7, fragrance, DMDM hydantoin, polyquaternium-7, citric acid, glycerin, tetrasodium EDTA, aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzophenone-4, hydrolyzed silk, FD&C yellow no. 5, D&C red no. 33

Questions or Comments?

Call toll-free 1-800-443-0602

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

MADE IN
USA

PRINCIPAL DISPLAY PANEL - 221 mL Label

FOR THE GOOD HEALTH
OF YOUR SKIN

New
Protex®
OATS

Antibacterial Liquid Hand Soap
with Natural Oils

DERMATOLOGIST
TESTED

54172

7.5 FL OZ (221 mL)

PROTEX OATS 
triclocarban liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-834
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclocarban (UNII: BGG1Y1ED0Y) (Triclocarban - UNII:BGG1Y1ED0Y)	Triclocarban	1.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium C14-16 olefin sulfonate (UNII: O9W3D3YF5U)
Lauric Diethanolamide (UNII: I29I2VHG38)
glycol stearate (UNII: 0324G66D0E)
PPG-2 hydroxyethyl cocamide (UNII: 34N07GUJ3X)
Sodium chloride (UNII: 451W47IQ8X)
Cocamidopropyl betaine (UNII: 5OCF3O11KX)
Laureth-7 (UNII: Z95S6G8201)
DMDM hydantoin (UNII: BYR0546TOW)
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) (UNII: 0L414VCS5Y)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Edetate Sodium (UNII: MP1J8420LU)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
oat (UNII: Z6J799EAJK)
sulisobenzone (UNII: 1W6L629B4K)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	YELLOW (Light Yellow, tan)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-834-75	221 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/11/2010	12/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	02/11/2010	12/30/2016

Labeler - Colgate Palmolive Company (068693167)

Revised: 6/2019

Document Id: 8efb4b88-8cee-4934-bb9d-09cbfdfc5a5f

34390-5

Set id: 46037aff-de59-4da8-b456-6285cd954399

Version: 2

Effective Time: 20190621