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Antibacterial Foaming Skin Cleanser

Medically reviewed on July 19, 2017

Dosage form: soap
Ingredients: BENZALKONIUM CHLORIDE .13mg in 1mL
Labeler: Betco Corporation, Ltd.
NDC Code: 65601-709

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.

Antibacterial Foaming Skin Cleanser

​Active Ingredient

​Benzalkonium Chloride 0.13%

Uses

  • ​Antibacterial skin cleanser.
  • Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians offices.

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
  • Rinse with clean water.

Inactive Ingredients

​Water, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

ANTIBACTERIAL FOAMING SKIN CLEANSER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-709
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POTASSIUM COCOATE 
PROPYLENE GLYCOL 
GLYCERIN 
EDETATE SODIUM 
BRONOPOL 
SODIUM CITRATE 
MAGNESIUM NITRATE 
SODIUM GLYCOLATE 
ALCOHOL 
ALOE VERA LEAF 
TRISODIUM NITRILOTRIACETATE 
FD&C YELLOW NO. 5 
SODIUM HYDROXIDE 
METHYLCHLOROISOTHIAZOLINONE 
MAGNESIUM CHLORIDE 
METHYLISOTHIAZOLINONE 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:65601-709-291000 mL in 1 BAG
2NDC:65601-709-55208000 mL in 1 DRUM
3NDC:65601-709-043780 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/19/2017
Labeler - Betco Corporation, Ltd. (070307547)
Registrant - Betco corporation, Ltd. (070307547)
Establishment
NameAddressID/FEIOperations
Betco Corporation, Ltd.070307547manufacture(65601-709), pack(65601-709), label(65601-709)

 
Betco Corporation, Ltd.

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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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