ANTIMICROBIAL- triclosan soap 
Chester Packaging, LLC

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

Antimicrobial

Uses

  • Handwash to help reduce bacteria that potentially can cause disease.

Warnings

  • For external use only.

When using this product

  • Avoid contact with eyes. In case of eye contact, flush with water.
  • Consult your doctor before use if you have any deep wounds, animal bites or serious burns.

Stop use and ask a doctor if

  • irritation or redness develops. If condition persists, seek medical attention.

Keep out of reach of children.

  • If swallowed, seek immediate medical attention or call a Poison Control Center.

Directions

  • Wet hands, apply soap, rub hands together vigorously for at least 15 seconds. Rinse and dry hands thoroughly with a disposable paper towel.

Inactive ingredients

Water/Aqua, Sodium Lauryl Sulfate, Sodium C14-16 Sulfonate, Cocamidopropyl Betaine, Cocamide DEA, Glycerin, Disodium R-MEA Sulfosuccinate, Ammonium Chloride, Fragrance, Methylchloroisothiazolinone and Methylisothazolinone, Citric Acid, FD&C Yellow #5, FD&C Red #4.

Package/Label Principal Display Panel

Antimicrobial Liquid Soap

S8340

GP

Georgia-Pacific

Professional

Atlanta, GA 30303

Cormatic®

Antimicrobial Liquid Soap

Chamomile, Gold

4 - 3 Liter (101.4 U.S. fl oz)

ANTIMICROBIAL 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12462-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12462-400-034 in 1 CASE
13000 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:12462-400-1010 in 1 CASE
21000 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:12462-400-128 in 1 CASE
31200 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:12462-400-133800 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:12462-400-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/200912/31/2017
Labeler - Chester Packaging, LLC (004237806)

Revised: 1/2016
Document Id: 2a3ee26f-7f8b-39e9-e054-00144ff8d46c
Set id: 0256b301-95c6-4952-8c71-32f8a16d3a01
Version: 2
Effective Time: 20160126
 
Chester Packaging, LLC