Label: KVG GROUP, INC. FXP CRACKED HEEL FORMULA- dimethicone spray

  • 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 January 17, 2020

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  • Active Ingredients

    Dimethicone 1%

  • Purpose

    Skin protectant

  • Footlogix TM

    Cracked Heel Formula: Moisturizes and protects extremely callused, cracked skin

    • Natural skin functions remain unhindered
    • Is absorbed immediately without any greasy residue
    • Clothing can be worn immediately after application
    • Free of perfumes
    • Dermatologist tested
  • Warnings

    For external use only

    • Avoid spraying into the eyes

    Do not use on deep wounds, animal bites or serious burns

    Caution:

    Contents are under pressure

    • Protect from direct sunlight and do not store at temperatures above 120ºF / 50ºC
    • After use, do not puncture or incinerate container
    • Spray only in a well ventilated area
    • Do not spray in the presence of an open flame, spark or while smoking

    Stop use and ask a doctor if: Condition worsens

    • symptoms last more than 7 days or clear up and re-occur within a few days

    If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions:

    Clean the affected area and dry thoroughly

    • Hold can upright
    • Shake can 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
    • Supervise children in the use of this product
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Butane, Cetearyl Ethylhexanoate, Disodium EDTA, Glycerin, Stearic Acid, Methylparaben, Oenothera Biennis Oil, Phenoxyethanol, Polysorbate 20, Propane, Propylene Glycol, Propylparaben, PVP, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

  • FXP Cracked Heel Formula

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    KVG GROUP, INC.  FXP CRACKED HEEL FORMULA
    dimethicone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0114-3125 mL in 1 CAN; Type 0: Not a Combination Product05/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/21/2014
    Labeler - Prime Packaging Inc. (805987059)
    Registrant - Prime Packaging Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028analysis(13630-0114) , manufacture(13630-0114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging Inc.805987059pack(13630-0114) , label(13630-0114)
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