ROYAL ANTIBACTERIAL ORANGE BERRY 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 ORANGE BERRY HAND CLEANSE 
triclosan gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-105
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:50438-105-01 500 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/17/2013
Labeler - Filo America (943873703)
Establishment
Name Address ID/FEI Business Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(50438-105)

Revised: 9/2013
Document Id: 0c57dc16-b5f4-4cbe-82a4-77d3fa9798f8
Set id: 1ca2466c-90b4-4af9-8fae-6d0d71ee0d6d
Version: 1
Effective Time: 20130917
 
Filo America