ANTI-BACTERIAL FOAMING  - triclosan soap 
Tri-Coastal Design Company 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 0.1%

Purpose

Antiseptic

Uses

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

Other information

Inactive Ingredients

Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DC Orange 4, Disodium EDTA, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Sodium Laureth Sulfate, Water

Package Label

Package Label
image of package label



ANTI-BACTERIAL FOAMING  
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZOPHENONE (UNII: 701M4TTV9O)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49852-013-08240 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/15/2011
Labeler - Tri-Coastal Design Company Inc. (609734900)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture

Revised: 8/2011
Document Id: 2e5bfee7-c831-4ae1-9ce8-070b950ca9a9
Set id: b3b1c9bf-f705-46e6-825d-be3048772d85
Version: 1
Effective Time: 20110812
 
Tri-Coastal Design Company Inc.