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Royal Antibacterial (coconut and lime) moisturizing hand cleanse

Medically reviewed on June 5, 2018

Dosage form: gel
Ingredients: TRICLOSAN 1.5mg in 1mL
Labeler: Filo America
NDC Code: 50438-603

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.

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
  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.

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

ROYAL ANTIBACTERIAL (COCONUT AND LIME) MOISTURIZING HAND CLEANSE 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-603
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 LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM LAURYL SULFATE 
SODIUM CHLORIDE 
PEG-150 DISTEARATE 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:50438-603-01444 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/05/2015
Labeler - Filo America (943873703)
Establishment
NameAddressID/FEIOperations
Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(50438-603)

 
Filo America

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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