ANTIBACTERIAL GOLD - triclocarban soap
Kareway Product, Inc.

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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Active Ingredient

Triclocarban 0.10%

Purpose

Antibacterial

Use

For washing to decrease bacteria on the skin

Warnings

For external use only

Avoid contact with eyes. In case of eye contact, flush with water.
Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet bar with water
Lather vigorously and wash skin
Rinse and dry thoroghly

Inactive Ingredient

BHT, DC yellow no.8, FDC red no.4, FDC yellow no.5, glycerin, palmitic acid, PEG-6 methyl ether, pentasodium pentetate, sodium chloride, sodium palmitate, sodium palm kernelate, sorbitol, tetrasodium etidronate, water

Package label

Pure Antibacterial image of package label

ANTIBACTERIAL GOLD
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67510-0016
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOCARBAN (TRICLOCARBAN)	TRICLOCARBAN	.1 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 8
FD&C RED NO. 4
FD&C YELLOW NO. 5
GLYCERIN
PALMITIC ACID
PEG-6 METHYL ETHER
PENTASODIUM PENTETATE
SODIUM CHLORIDE
SODIUM PALMITATE
SODIUM PALM KERNELATE
SORBITOL
ETIDRONATE TETRASODIUM
WATER
BUTYLATED HYDROXYTOLUENE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67510-0016-3	3 BOX ( BOX) in 1 CELLO PACK	contains a BOX
1		100 g in 1 BOX	This package is contained within the CELLO PACK (67510-0016-3)
2	NDC:67510-0016-2	2 BOX ( BOX) in 1 CELLO PACK	contains a BOX
2		100 g in 1 BOX	This package is contained within the CELLO PACK (67510-0016-2)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/07/2011

Labeler - Kareway Product, Inc. (121840057)

Revised: 09/2011 Kareway Product, Inc.