PACIFIC ANTI-BACTERIAL HAND CLEANSE BLUEBERRY ESSENCE- triclosan gel 
Filo America

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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Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

Uses

for handwashing to eliminate bacteria and germs on the skin.

Keep away from children, except of under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

Warnings

For external use only.

When using this productl, avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water.

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

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

label image

PACIFIC ANTI-BACTERIAL HAND CLEANSE BLUEBERRY ESSENCE 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50438-102-01500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/08/2013
Labeler - Filo America (943873703)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-102)

Revised: 8/2013
Document Id: 515c193f-3aae-4fd0-b905-584e18c1ee79
Set id: 81774cce-a00d-41e4-8469-f0fdb141658b
Version: 1
Effective Time: 20130808
 
Filo America