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KLEENFOAM

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:

Antiseptic Handwash

Uses:
  • For handwashing to decrease bacteria on the skin.
  • after changing diapers;
  • after assisting ill persons;
  • before contact with a person under medical care or treatmentRecommended 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:

For external use only.

Avoid contact with eyes. In case of contact, flush thoroughly with water.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

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

Directions:
  • Wet hands and forearms.
  • Apply 5 millimeters (teaspoon) or palmful to hands and forearms.
  • Scrub thoroughly for 15 seconds.
  • Rinse and repeat.

Other information:

Store at room temperature (59°-86°F). You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

Water, Sodium Lauryl sulfate, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Polysorbate 20, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Disodium EDTA, Sodium Isostearoyl lactylate, Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Citric Acid, Sodium Hydroxide

Question?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

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

Medically reviewed on Sep 14, 2018

Further information

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

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