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Antibacterial by Brands International Corp

Dosage form: liquid
Ingredients: TRICLOSAN 1.15mg in 100mL
Labeler: Brands International Corp
NDC Code: 50157-201

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 0.115%

Purpose - Antibacterial

Use for handwashing to decrease bacteria on the skin

Warnings

For external use only - hands only

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or redness develops n condition persists for more than 72 hours

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

Directions

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly

Inactive Ingredients - Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Lauroamphoacetate, Polyquaternium 7, Glycerin, Citric Acid, Aloe Barbadensis Leaf Extract, Tocopheryl (Vitamin E) Acetate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Red 4 (Cl 14700)

ANTIBACTERIAL 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN1.15 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
FD&C RED NO. 4 
METHYLCHLOROISOTHIAZOLINONE 
WATER 
SODIUM LAURETH SULFATE 
SODIUM CHLORIDE 
COCAMIDOPROPYL BETAINE 
SODIUM LAUROAMPHOACETATE 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
GLYCERIN 
ANHYDROUS CITRIC ACID 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
Packaging
#Item CodePackage Description
1NDC:50157-201-24709 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/06/2016
Labeler - Brands International Corp (243748238)
Establishment
NameAddressID/FEIOperations
Brands International Corp243748238manufacture(50157-201)

Revised: 05/2016
 
Brands International Corp

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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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