ANTIBACTERIAL BAR - triclosan soap
Charm-Tex, 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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DRUG FACTS

Active Ingredient

Triclosan 0.3%

Purpose

Antibacterial

USES

For washing to decrease bacteria on the skin.

WARNINGS

For external use only.

When using this product

avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask 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.
Later vigorously and wash skin.
Rinse and dry thoroughly.

INACTIVE INGREDIENTS

Sodium Palmitate, Sodium Cocoate, Water, Glycerin, Fragrance, Sodium Chloride, EDTA, BHT.

Charm-Tex, Inc. Brooklyn NY 11230

PRINCIPAL DISPLAY PANEL - 1.4 gr Bar Soap Carton

Charm-Tex

PROVIDERS OF
CORRECTIONAL SUPPLIES

ANTIBACTERIAL BAR SOAP
WRAPPED

Style Number #H/S1/2
Contents: 1,000
Net Wt. 0.5 oz. (1.4gr) Each

PRINCIPAL DISPLAY PANEL - 1.4 gr Bar Soap Carton

ANTIBACTERIAL BAR
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:40057-3000
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclosan (Triclosan)	Triclosan	0.3 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
Sodium Palmitate
Sodium Cocoate
Water
Glycerin
Sodium Chloride
Edetic Acid

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:40057-3000-1	1000 PACKAGE ( PACKAGE) in 1 CARTON	contains a PACKAGE
1		14.17 g in 1 PACKAGE	This package is contained within the CARTON (40057-3000-1)
2	NDC:40057-3000-2	500 PACKAGE ( PACKAGE) in 1 CARTON	contains a PACKAGE
2		42.52 g in 1 PACKAGE	This package is contained within the CARTON (40057-3000-2)
3	NDC:40057-3000-3	144 PACKAGE ( PACKAGE) in 1 CARTON	contains a PACKAGE
3		85 g in 1 PACKAGE	This package is contained within the CARTON (40057-3000-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	02/29/2012

Labeler - Charm-Tex, Inc (058347543)

Revised: 03/2012 Charm-Tex, Inc