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Antibacterial by Sante Manufacturing Inc

Medically reviewed on January 30, 2018

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 1.3mg in 1mL
Labeler: Sante Manufacturing Inc
NDC Code: 71020-004

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.

Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

Uses for handwashing or decrease bacteria to the skin

Warnings For external use only

Stop use and ask a doctor if irritation or redness develops

When using this product

  • do not get it into eyes. If contact occurs, rinse eye thoroughly with water

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

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl 14700)

ANTIBACTERIAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
GLYCERIN 
DITETRACYCLINE TETRASODIUM EDETATE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
FD&C RED NO. 4 
ANHYDROUS CITRIC ACID 
Packaging
#Item CodePackage Description
1NDC:71020-004-641900 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/08/2016
Labeler - Sante Manufacturing Inc (242048747)
Registrant - Sante Manufacturing Inc (242048747)
Establishment
NameAddressID/FEIOperations
Brands International Corporation243748238manufacture(71020-004), label(71020-004)

 
Sante Manufacturing Inc

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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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