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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Antibacterial Bar Soap

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

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 (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan 0.3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
Sodium Palmitate (UNII: JQ43KP6296)  
Sodium Cocoate (UNII: R1TQH25F4I)  
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Chloride (UNII: 451W47IQ8X)  
Edetic Acid (UNII: 9G34HU7RV0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:40057-3000-1 1000 in 1 CARTON
1 14.17 g in 1 PACKAGE
2 NDC:40057-3000-2 500 in 1 CARTON
2 42.52 g in 1 PACKAGE
3 NDC:40057-3000-3 144 in 1 CARTON
3 85 g in 1 PACKAGE
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: 10/2012
Document Id: 76233513-b690-44a9-89fc-7b2744bb6a18
Set id: e63d89d0-cb5b-49cb-8564-b91dfc76af85
Version: 2
Effective Time: 20121009
 
Charm-Tex, Inc