ROYAL ANTIBACTERIAL (MANGO)- 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

Triclosan 0.15%

Purpose

Antibacterial

Uses

for handwashing 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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Chloride, Fragrance, Citric Acid, Peg-150 Distearate, Tetrasodium Edta, FD&C Yellow No.5, FD&C Blue No.1

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ROYAL ANTIBACTERIAL (MANGO) 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-601
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 LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50438-601-01221 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/05/2015
Labeler - Filo America (943873703)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(50438-601)

Revised: 6/2015
Document Id: 1255fcfa-030c-48b7-82aa-844840b9a863
Set id: 98664eda-8236-462f-88d4-2516ea8c6c06
Version: 1
Effective Time: 20150605
 
Filo America