Label: SIMPLY FIRM - BODY GELCREME- dimethicone gel

  • 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 April 23, 2013

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  • ACTIVE INGREDIENT

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

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

  • 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
  • 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
  • KEEP OUT OF REACH OF CHILDREN

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

  • 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
  • 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.

  • DOSAGE & ADMINISTRATION

    8 fl oz / 240 fl ml

  • PRINCIPAL DISPLAY PANEL

    label
    Simply Firm Body - GelcremeSkin and tissue firming
  • INGREDIENTS AND APPEARANCE
    SIMPLY FIRM - BODY  GELCREME
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51439-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone.0024 mg  in .024 mg
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    LEVOCARNITINE (UNII: 0G389FZZ9M)  
    DEANOL (UNII: 2N6K9DRA24)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MINT (UNII: FV98Z8GITP)  
    ALMOND (UNII: 3Z252A2K9G)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51439-003-01.024 mg in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/05/2012
    Labeler - CarePluss Pharma S.A. de C.V. (815061551)
    Registrant - CarePluss Pharma S.A. de C.V. (815061551)
    Establishment
    NameAddressID/FEIBusiness Operations
    CarePluss Pharma S.A. de C.V.815061551manufacture(51439-003)