ANTIBACTERIAL  - triclosan 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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Antibacterial



Active Ingredient

Triclosan 0.2%



Purpose  antibacterial



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

Uses

for hand washing to decrease bacteria on the skin.



Warnings

For external use only.

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

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



Directions

Pump into hands

Lather vigorously for at least 15 seconds

Rinse and dry thoroughly

Inactive ingredients

Water (aqua), sodium laureth sulfate, sodium chloride, coamide DEA, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, yellow #5, red #40

label


Kills 99% of germs

Antibacterial soap

Moisterizing hand soap

15 fl oz (444 ml)

ANTIBACTERIAL  
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.888 mL  in 444 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-903-85444 mL in 1 BOTTLE, PUMP
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 Pulisi Daily Chemical Products529047265manufacture
Establishment
NameAddressID/FEIBusiness Operations
Ningbo United Group Co Ltd544900137manufacture
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Unichem Household Products Co Ltd528196956manufacture

Revised: 10/2011
Document Id: 9fc68949-3cb7-4c68-893d-3408a9501a31
Set id: f4833746-1d9f-47d4-abd7-8cbac88845f2
Version: 4
Effective Time: 20111026
 
Personal Care Products LLC