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anti-bacterial foaming by Tri-Coastal Design Company Inc.

Medically reviewed on August 13, 2018

Dosage form: soap
Ingredients: TRICLOSAN 0.1mL in 100mL
Labeler: Tri-Coastal Design Company Inc.
NDC Code: 49852-005

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.

Drug Facts

Active Ingredient

Triclosan 0.1%

Purpose

Antiseptic

Uses
  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings For external use only

When using this product
  • avoid the eyes and mucous membranes
  • in the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop use and ask a doctor if
  • condition worsens
  • redness or irritation develops
  • if condition persists for more than 3 days

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions
  • Wet hands, work into a lather. Rinse well
  • supervise children in the use of this product
  • in the case of eye contact, rinse eyes thoroughly with water

Other information
  • store below 105F
  • may discolor some fabrics

Inactive IngredientsBenzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, FDC Blue 1, FDC Yellow 5, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Sodium Laureth Sulfate, Water

Package LabelPackage Label



ANTI-BACTERIAL FOAMING  
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZOPHENONE 
CITRIC ACID MONOHYDRATE 
COCO DIETHANOLAMIDE 
COCAMIDOPROPYL BETAINE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
PEG-150 DISTEARATE 
SODIUM LAURETH SULFATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:49852-005-08240 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/FEIOperations
Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture

 
Tri-Coastal Design Company Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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