KLEENFOAM (OTC ANTIMICROBIAL DRUG PRODUCT) AEROSOL, FOAM [DERMARITE INDUSTRIES LLC]

KLEENFOAM (OTC ANTIMICROBIAL DRUG PRODUCT) AEROSOL, FOAM [DERMARITE INDUSTRIES LLC]
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NDC 61924-093-34
Set ID f4ea9ae8-c783-48b4-af31-a26ecaa34992
Category HUMAN OTC DRUG LABEL
Packager Dermarite Industries LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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

  • INGREDIENTS AND APPEARANCE
    KLEENFOAM 
    otc antimicrobial drug product aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-093
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LEMON OIL (UNII: I9GRO824LL)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-093-341000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product12/12/2011
    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/FEIBusiness Operations
    Dermarite Industries LLC883925562manufacture(61924-093)

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