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Antibacterial by Brands International Corporation

Medically reviewed on July 7, 2017

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 1.3mg in 1000mL
Labeler: Brands International Corporation
NDC Code: 50157-207

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 - Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

Use for handwashing to decrease bacteria on skin

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 and if condition persists for more than 72 hours

keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Direction

* wet hands

* apply to hands

* scrub thoroughly

* rinse thoroughly

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Tetra Sodium EDTA, Methylchloroisothiazolinone, Methylisthiazolinone, Red # 33 (Cl 17200), Blue# 1(42090), Fragrance (Parfum)

ANTIBACTERIAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-207
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1.3 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C BLUE NO. 1 
SODIUM CHLORIDE 
ANHYDROUS CITRIC ACID 
GLYCERIN 
ETIDRONATE TETRASODIUM 
METHYLCHLOROISOTHIAZOLINONE 
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:50157-207-25739 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2017
Labeler - Brands International Corporation (243748238)
Establishment
NameAddressID/FEIOperations
Brands International Corporation243748238manufacture(50157-207)

 
Brands International Corporation

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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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