Protex® BALANCE

Drug Labeling and Warnings

Drug Details [pdf]

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

PROTEX   BALANCE ANTIBACTERIAL HAND
triclocarban liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-850
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 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (Yellow/Orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-850-19	590 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2011	12/31/2015
2	NDC: 35000-850-12	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2011	12/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/10/2011	12/31/2015

Labeler - Colgate-Palmolive Company (068693167)

Revised: 8/2017

Document Id: 6a5cd299-5907-4926-abe0-f911e437f4df

34390-5

Set id: a29f2d08-a7df-4296-aec5-f2217361a9a2

Version: 6

Effective Time: 20170807