PERSONAL CARE ANTIBACTERIAL  - triclocarben soap 
Personal Care Products 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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Personal Care Antibacterial



Active ingredient               Purpose

Triclocarban .78%              Antibacterial



Stop use and ask a doctor if irritation or redness develops.



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.



Purpose   Antibacterial



When using this product avoid contact eyes. In case of eye contact, flush with plenty of water.



Stop use and ask a doctor if irritation or redness develops.



Directions



Uses for washing to decrease bacteria on the skin.



Inactive ingredients  sodium tallowate, sodium cocoate, sodium palm kernalate, sodium palmitate, cocnut acid, glycerin, sodium chloride, sorbitol, water(aqua), fragrance, titanium dioxide, BHT, disodium EDTA,



warnings For external use only

label


Personal Care

Antibacterial Soap

Long lasting Deodorant protection

2 bars

3 oz (86 g)ea (Total net wt 6 oz)

PERSONAL CARE ANTIBACTERIAL  
triclocarben soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y) TRICLOCARBAN.67 g  in 86 g
Inactive Ingredients
Ingredient NameStrength
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
SODIUM COCOATE (UNII: R1TQH25F4I)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
SODIUM PALMITATE (UNII: JQ43KP6296)  
COCONUT ACID (UNII: 40U37V505D)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-9208-086 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2011
Labeler - Personal Care Products LLC (966155082)
Registrant - Personal Care Products LLC (966155082)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Unichem Household Prodcuts Co Ltd528196956manufacture
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Soap Co Ltd545258233manufacture

Revised: 1/2012
Document Id: ec7f2d22-ffc3-4609-b8dc-20934afe30c5
Set id: 61c0381e-828f-42c6-ba52-3cb1a5d1917e
Version: 2
Effective Time: 20120111
 
Personal Care Products LLC