Label: SIMPLY FIRM - BODY GELCREME- dimethicone gel 

  • Label RSS
  • NDC Code(s): 51439-003-01
  • Packager: CarePluss Pharma S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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

  • ACTIVE INGREDIENT

    Active Ingredients...........Purpose

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

    Close
  • PURPOSE

    Uses: protects from minor skin irritations.

    • temporarily protects injured or exposed skin
    • slows the loss of water of the skin by forming a barrier on the skin's surface
    • enhances the appearance of dry or damaged skin
    • increases the water content of the top layers of the skin
    • is a lubricant for the surface of the skin
    • gives skin a soft and smooth appearance
    Close
  • WARNINGS

    Warnings: For external use only

    • when using this product skin irritation may occur
    • some medicines may interact with dimethicone, however, no specific interactions are known at this time


    Do not use

    • if you are allergic to any ingredients listed
    • if you have sensitive skin and/or are sensitive to Dimethicone
    • do not use if you are pregnant, planning to become pregnant, or breast feeding
    • if you have an open wound, burn, damaged or irritaed skin


    When using this product

    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling
    • should irritation occur lesson frequency of use
    • avoid unnecessary sun exposure and use a 45 SPF sun screen when going outside


    Stop use and ask a doctor if:

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • any of these severe effects occur; allergic reaction, irritation becomes severe i.e. persistent rash, hives, itching, burning, difficulty breathing, swelling
    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately

    Close
  • INDICATIONS & USAGE

    Directions:

    • cleanse gently
    • apply to body
    • massage into desired area using long upward strokes
    • start with a single application, gradually increase to as many applications as desired
    • when going outside be sure to use a 45 SPF SUN SCREEN applicable to the area
    • if excessive irritation or sensitivity develops stop use of product and contact a physician
    Close
  • INACTIVE INGREDIENT

    Other ingredients: Water, Almond Oil, Glycerin, Cetearyl alcohol, Cetearteh-12, almond Oil, L-Carnitine, DMAE, Bitartrate, Sodium Ascorbyl Fosphate,, Sunflower Seed Oil, Green Tea extract, Coffee extract, Sodium Dodecyl Sulphate, Base Lemon Grass, Pepermint Oil, Menthol, Ultrex 21, Green Tea scent, EDTA, BHT, BHA.

    Close
  • DOSAGE & ADMINISTRATION

    8 fl oz / 240 fl ml

    Close
  • PRINCIPAL DISPLAY PANEL

    label
    Simply Firm Body - Gelcreme Skin and tissue firming Close
  • INGREDIENTS AND APPEARANCE
    SIMPLY FIRM - BODY  GELCREME
    dimethicone gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51439-003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (Dimethicone) Dimethicone .0024 mg  in .024 mg
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    CETYL ALCOHOL  
    CETEARETH-12  
    ALMOND OIL  
    LEVOCARNITINE  
    DEANOL  
    SODIUM ASCORBYL PHOSPHATE  
    SUNFLOWER OIL  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    WEST INDIAN LEMONGRASS OIL  
    TROLAMINE  
    SODIUM DODECYLBENZENESULFONATE  
    ASCORBIC ACID  
    PEPPERMINT OIL  
    MINT  
    ALMOND  
    GREEN TEA LEAF  
    EDETIC ACID  
    METHYLPARABEN  
    PROPYLPARABEN  
    BUTYLATED HYDROXYTOLUENE  
    BUTYLATED HYDROXYANISOLE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51439-003-01 .024 mg in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/05/2012
    Labeler - CarePluss Pharma S.A. de C.V. (815061551)
    Registrant - CarePluss Pharma S.A. de C.V. (815061551)
    Establishment
    Name Address ID/FEI Business Operations
    CarePluss Pharma S.A. de C.V. 815061551 manufacture(51439-003)
    Close