PROTEX BALANCE ANTIBACTERIAL HAND- benzalkonium chloride liquid

Protex Balance antibacterial hand by

Drug Labeling and Warnings

Protex Balance antibacterial hand by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

helps eliminate bacteria 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. Unique Formula. Refill only with Protex

Inactive ingredients

water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, citric acid, fragrance, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow No. 5, D&C red No. 33

Questions?

Call toll-free 1-800-443-0602

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

Eliminates 99.9% of Bacteria*

Protex®

For the Good Health of your Skin
Daily Protection Against Bacteria

BALANCE
DERMATOLOGIST
TESTED

Antibacterial Liquid Hand Soap

9904820
7.5 FL OZ (221 mL)

INGREDIENTS AND APPEARANCE

PROTEX BALANCE ANTIBACTERIAL HAND 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-675
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.33 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-675-75	221 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2013
2	NDC: 35000-675-12	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	08/22/2013

Labeler - Colgate-Palmolive (001344381)