ROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE- 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 decrease bacteria on the skin.

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

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

Warnings

For external use only.

Avoid getting into eyes. If this happens, rinse thoroughly with water.

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

ROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50438-108
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
SODIUM LAURETH SULFATE 
COCO DIETHANOLAMIDE 
SODIUM CHLORIDE 
PEG-150 DISTEARATE 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
EDETATE DISODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLCHLOROISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50438-108-01500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/17/2013
Labeler - Filo America (943873703)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-108)

Revised: 9/2013
Document Id: 701409ce-fddc-4257-baeb-e18939be1d55
Set id: f3399ba7-231a-4c74-be4a-9890d4001666
Version: 1
Effective Time: 20130917
 
Filo America