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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:40057-3000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (Triclosan) Triclosan0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Sodium Palmitate 
Sodium Cocoate 
Water 
Glycerin 
Sodium Chloride 
Edetic Acid 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40057-3000-11000 in 1 CARTON
114.17 g in 1 PACKAGE
2NDC:40057-3000-2500 in 1 CARTON
242.52 g in 1 PACKAGE
3NDC:40057-3000-3144 in 1 CARTON
385 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E02/29/2012
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