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KLEENFOAM

Medically reviewed on April 6, 2018

Dosage form: aerosol, foam
Ingredients: CHLOROXYLENOL 0.005g in 1mL
Labeler: Dermarite Industries LLC
NDC Code: 61924-093

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.

DRUG LISTING: KLEENFOAM

Active Ingredient

Chloroxylenol 0.5%

Purpose:

Antimicrobial

Uses:
  • For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Warnings:
  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Ask a doctor before use if you have , deep of puncture wounds, animal bites, serious burns
  • When using this product, do not apply to areas of raw or blistered skin in large quantities, do not use in or near the eyes
  • Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days or clear up and recur within a few days

Warnings:

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away

Directions:

Apply to soiled and/or odorous areas. Wipe gently with soft cloth. Repeat as necessary until all soils are removed and skin is clean. Pat dry. No need to rinse.

Other information:

Store at room temperature (59°-86°F)

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Disodium EDTA,DMDM Hydantoin, Lemon Oil, Methychloroisothiazoline, Methyliisothiazoline, Methylparaben, Polysorbate 20, Propylene Glycol, PropylParaben, Sodium Chloride, Sodium Isostearoyl Lactylate, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Water

Question?

Call 1-800-337-6296

Kleenfoam Package Label Principal Display Panel

KLEENFOAM 
otc antimicrobial drug product aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-093
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL0.005 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CITRIC ACID MONOHYDRATE 
COCO MONOETHANOLAMIDE 
COCAMIDOPROPYL BETAINE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SODIUM LAURETH SULFATE 
SODIUM LAURYL SULFATE 
PROPYLENE GLYCOL 
DMDM HYDANTOIN 
METHYLPARABEN 
PROPYLPARABEN 
EDETATE SODIUM 
SODIUM HYDROXIDE 
SODIUM CHLORIDE 
LEMON OIL 
POLYSORBATE 20 
SODIUM ISOSTEAROYL LACTYLATE 
WATER 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61924-093-341000 mL in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/12/2011
Labeler - Dermarite Industries LLC (883925562)
Registrant - Dermarite Industries LLC (883925562)
Establishment
NameAddressID/FEIOperations
Dermarite Industries LLC883925562manufacture(61924-093)

 
Dermarite Industries LLC

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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