Label: FOOTLOGIX INTENSIVE CARE DIABETIC FORMULA- clotrimazole aerosol, foam

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated June 20, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient
    Clotrimazole 1%
  • PURPOSE

    Purpose
    Antifungal
  • INDICATIONS & USAGE

    Use Footlogix Intensive Diabetic Formula: - with Dermal Infusion Technology for the cure and prevention of fungal infections associated with Athlete’s foot fungus. This Anti-fungal, intensivecare formulation provides effective relief of itching, scaling, cracking, burning, redness and irritation of the skin. Natural skin functions remain unhindered.
  • WARNINGS

    Warnings ■ Do not use under children 2 years of age unless directed by a doctor ■ For external use only ■ Avoid spraying into the eyes ■ Do not use on deep wounds, infections or lacerations ■ Supervise children in the use of this product
  • ASK DOCTOR

    Stop use and ask a doctor if: ■ irritation occurs or if there is no improvement within 4 weeks ■ there are deep puncture wounds, infections or lacerations

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions ■ Clean the affected area and dry thoroughly ■ Hold the can upright ■ Shake well before each use ■ Use sparingly twice daily for the first two weeks and continue once daily until the problem is corrected  ■ When used as directed, this can contains enough mousse for approximately two months supply ■ If condition persists, consult a doctor
  • SPL UNCLASSIFIED SECTION

    Caution: ■  Contents are under pressure ■  Protect from direct sunlight and do not store at temperatures above 120F/50C ■  After use, do not puncture or incinerate container ■  Spray only in a well ventilated area ■  Do not spray in presence of open flame or spark or while smoking

  • INACTIVE INGREDIENT

    Inactive Ingredients Aloe Barbadensis Leaf Juice, Cetearyl Ethylhexanoate, Dimethicone, Disodium EDTA, Glycerin, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    FOOTLOGIX INTENSIVE CARE  DIABETIC FORMULA
    clotrimazole aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42479-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42479-213-04119 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/15/2012
    Labeler - KVG Group Inc (206932605)
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