Label: FOOTLOGIX MOISTURIZING DIABETIC FORMULA- dimethicone 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 28, 2012

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Dimethicone 1%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses: Footlogix Moisturizing Diabetic Formula- with Dermal Infusion Technology is an effective daily maintenance formula that hydrates and relieves the extremely dry, cracked skin of the feet. This unique fragrance-free, lightweight mousse formula also softens, protects the skni and prevents damage due to dryness by replenishing the skin's moisture barrier.

  • WARNINGS

    Warnings ■ Do not use on 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, Butylene Glycol, Cetearyl Ethylhexanoate, Disodium EDTA, Glycerin, Isostearic Acid, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, SD Alcohol 40-B, Sorbitol, Spirulina Platensis Extract, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

  • PRINCIPAL DISPLAY PANEL

    Product Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    FOOTLOGIX  MOISTURIZING DIABETIC FORMULA
    dimethicone aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42479-214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)  
    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:42479-214-04119 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/15/2012
    Labeler - KVG Group Inc (206932605)