PANACHE  ANTIBACTERIAL BODY WASH - triclosan liquid 
Deb USA, 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 0.5%

Antibacterial

Uses

For washing to decrease bacteria on the skin

Warnings

For external use only

Avoid contact with the eyes

Keep out of reach of children

Consult with a physician if ingested

Directions

Dispense product onto washcloth or directly onto skin

Lather and wash for 15-20 seconds

Rinse thoroughly

Water, Sodium Laureth Sulfate, Propylene Glycol, Disodium Laureth Sulfosuccinate, Sodium Chloride, Cocamide DEA, Cocamidopropyl Betaine, Fragrance, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, FDC Red No. 40, FDC Yellow No. 5.


container label

PANACHE   ANTIBACTERIAL BODY WASH
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan.55 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sodium Laureth Sulfate (UNII: BPV390UAP0)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
Sodium Chloride (UNII: 451W47IQ8X)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Edetate Sodium (UNII: MP1J8420LU)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-115-34118 mL in 1 BOTTLE, PLASTIC
2NDC:11084-115-271000 mL in 1 CARTRIDGE
3NDC:11084-115-072000 mL in 1 CARTRIDGE
4NDC:11084-115-053780 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2010
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Deb USA, Inc.607378015manufacture

Revised: 2/2011
Document Id: 675bfd17-dfae-4e7d-bdac-41674b9e63d4
Set id: 397057de-4ed3-4e3b-a755-f3fc3e6ba5b5
Version: 9
Effective Time: 20110223
 
Deb USA, Inc.