Simply Firm - Body
FDA Label NDC 51439-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carepluss Pharma S.a. De C.v. for the product Simply Firm - Body (NDC 51439-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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