Label: DIABETIC FOOT CREAM PROFESSIONAL- dimethicone cream

  • 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 May 9, 2021

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  • Active Ingredient

    Dimethicone 1%..............................Skin Protectant

  • Purpose

    Skin Protectant

  • Uses

    Helps prevent and temporarily protects chafed, chapped, or cracked skin.

  • Warnings

    For external use only.

  • When using this product

    do not get into the eyes

  • Stop use and ask physician if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed.

  • Other information

    Store at 20° – 25°C (68° – 77°F).

  • Inactive Ingredients

    Water, Propanediol, Ricinus Communis (Castor) Seed Oil, Lauryl Laurate, Arachidyl Alcohol, Inula Viscosa Flower/Leaf/Stem Extract, Stearyl Alcohol, Behenyl Alcohol, Glycerin, Synthetic Beeswax, Arachidyl Glucoside, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Limonene, Sodium Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Potassium Sorbate, Disodium EDTA, Xanthan Gum, Hydrolyzed Vegetable Protein, Citrus Aurantium Dulcis (Orange) Peel Oil, Leuconostoc/Radish Root Ferment Filtrate, Linalool, Citral

  • Questions?

    Call toll free 1-844-474-2552 or visit www.lavior.com

  • PRINCIPAL DISPLAY PANEL

    Diabetic Foot Cream Pro

  • INGREDIENTS AND APPEARANCE
    DIABETIC FOOT CREAM PROFESSIONAL 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-395
    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
    LAURYL LAURATE (UNII: GPW77G0937)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CITRAL (UNII: T7EU0O9VPP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71521-395-10100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/31/2021
    Labeler - Lavior Inc (080685327)
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