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Pacific Anti-bacterial Hand Cleanse Strawberry Essence

Medically reviewed on August 8, 2017.

Dosage form: gel
Ingredients: TRICLOSAN 1.5mg in 1mL
Labeler: Filo America
NDC Code: 50438-104

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                                   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

PACIFIC ANTI-BACTERIAL HAND CLEANSE STRAWBERRY ESSENCE 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-104
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 Description
1NDC:50438-104-01500 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/FEIOperations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(50438-104)

 
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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