Label: SIMPLY FIRM EYE - NON-SURGICAL FACE LIFT- dimethicone gel 

  • Label RSS
  • NDC Code(s): 51439-001-01
  • 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

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  • ACTIVE INGREDIENT

    Active Ingredient                 Purpose

    Dimethicone 1% ........ skin protectant

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  • 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
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  • 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 any of these severe side effects occur: allergic reaction, irritation become severe i.e. persistant rash, hives, itching, burning, difficulty breathing, swelling
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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS & USAGE

    Directions:

    • cleanse gently
    • apply SIMPLY FIRM 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
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  • INACTIVE INGREDIENT

    Other ingredients: Water, Almond Oil, Glycerin, Cetearyl alcohol, Cetearteh-12, Mineral Oil, L-Carnitine, DMAE bitartrate, Sodium Ascorbyl Fosphate, Carbomer, Green Tea extract, Coffe Berry extract, Trietanolamine, Sodium Lauryl Sulphate, Vitamin C, Pepermint Oil, Menthol, Almond scent, Green Tea scent, Coco scent, EDTA disodium.

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  • DOSAGE & ADMINISTRATION

    2 fl oz / 60 mL

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  • INGREDIENTS AND APPEARANCE
    SIMPLY FIRM EYE - NON-SURGICAL FACE LIFT 
    dimethicone gel gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51439-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 0.6 mg  in 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALMOND OIL  
    GLYCERIN  
    CETYL ALCOHOL  
    CETEARETH-12  
    MINERAL OIL  
    LEVOCARNITINE  
    DEANOL  
    SODIUM ASCORBYL PHOSPHATE  
    GREEN TEA LEAF  
    COFFEE BEAN  
    TROLAMINE  
    SODIUM DODECYLBENZENESULFONATE  
    ASCORBIC ACID  
    PEPPERMINT OIL  
    MINT  
    ALMOND  
    COCONUT  
    LIME (CITRUS)  
    EDETIC ACID  
    METHYLPARABEN  
    PROPYLPARABEN  
    BUTYLATED HYDROXYTOLUENE  
    BUTYLATED HYDROXYANISOLE  
    SUNFLOWER OIL  
    VITIS VINIFERA SEED  
    POMEGRANATE SEED OIL  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51439-001-01 60 mg in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 06/27/2012
    Labeler - CarePluss Pharma S.A. de C.V. (815061551)
    Establishment
    Name Address ID/FEI Business Operations
    CarePluss Pharma S.A. de C.V. 815061551 manufacture(51439-001)
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