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Antibacterial by Sante Manufacturing Inc

Medically reviewed on Jan 30, 2018

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 1.3mg in 1mL
Labeler: Sante Manufacturing Inc
NDC Code: 71020-001

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

For external use only

Stop use and ask a doctor if irritation or redness develops

When using the product

  • do not get 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 (Cl14700)

ANTIBACTERIAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-001
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
GLYCERIN 
DITETRACYCLINE TETRASODIUM EDETATE 
METHYLCHLOROISOTHIAZOLINONE 
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
ANHYDROUS CITRIC ACID 
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
FD&C RED NO. 4 
Packaging
#Item CodePackage Description
1NDC:71020-001-16500 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(71020-001), label(71020-001)

 
Sante Manufacturing Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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