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Protex

Colgate-Palmolive Company

Protex BALANCE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Protex

Triclocarban LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:35000-850
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Triclocarban TRICLOCARBAN 1.5 mg

Inactive Ingredients

Ingredient Name Strength
water
SODIUM C14-16 OLEFIN SULFONATE
LAURIC DIETHANOLAMIDE
COCAMIDOPROPYL BETAINE
LAURETH-7
SODIUM CHLORIDE
DMDM HYDANTOIN
CITRIC ACID MONOHYDRATE
EDETATE SODIUM
Aloe Vera Leaf
GLYCERIN
FD&C YELLOW NO. 5
D&C RED NO. 33

Product Characteristics

Color
YELLOW (Yellow/Orange)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35000-850-19 590 in 1 BOTTLE
2 NDC:35000-850-12 3780 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partE part333E 2011-06-10


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Be sure to consult your doctor before taking any medication!
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