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  5. Label Information: Simply Firm - Body Gelcreme

FDA Label for Simply Firm - Body Gelcreme

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. INDICATIONS & USAGE
    6. INACTIVE INGREDIENT
    7. DOSAGE & ADMINISTRATION
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Simply Firm - Body Gelcreme Product Label

The following document was submitted to the FDA by the labeler of this product Carepluss Pharma S.a. De C.v.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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

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


Otc - 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

Otc - 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


Package Label.Principal Display Panel



Simply Firm Body - GelcremeSkin and tissue firming

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