Label: MEDERMA PM- dimethicone cream

  • NDC Code(s): 0259-2202-28, 0259-2202-48
  • Packager: Merz Pharmaceuticals, LLC
  • 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 11/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients

    Dimethicone 2%

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  • Purpose

    Skin Protectant

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  • Use

    • Temporarily protects and helps relieve chapped or cracked skin
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  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    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

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

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

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  • Directions

    • Apply as needed.
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  • Other Information

    Store at room temperature.

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  • Inactive Ingredients

    Water, Cetearyl Alcohol, Glycerin, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Pentylene Glycol, Cyclomethicone, Arachidyl Alcohol, Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Allium Cepae (Onion) Bulb Extract, Copper Tripeptide-1, Aloe Barbadensis Leaf, Cetearyl Glucoside, Tocopherol Acetate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Hydrolyzed Soy Protein, Glycine, Panthenol, Hydrolyzed Collagen, PEG-400, Arginine HCL, Leucine, Lysine Hydrochloride, Alanine, Sodium Lactate, Aspartic Acid, Glucose, Glutamic Acid, Isopropyl Alcohol, Mannitol, Sorbitol, Tromethamine, Valine, Histidine Hydrochloride, Isoleucine, Phenylalanine, Tyrosine, Potassium Sorbate, Sodium Benzoate, Citric Acid, Sodium Hydroxide, Fragrance.

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  • Questions or Comments?

    For more information call 1-888-925-8989 or visit www.mederma.com

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  • PRINCIPAL DISPLAY PANEL - 28g Tube Box

    SKIN CARE FOR SCARS™
    MEDERMA® PM
    INTENSIVE OVERNIGHT SCAR CREAM

    Formulated to work with
    your skin's nighttime
    regenerative activity

    NEW

    Net Wt. 1.0 oz. (28g)

    Principal Display Panel - 28g Tube Box
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  • INGREDIENTS AND APPEARANCE
    MEDERMA PM 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0259-2202
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (Dimethicone) Dimethicone 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    water  
    Onion  
    Cetostearyl Alcohol  
    Glycerin  
    Dicaprylyl Carbonate  
    Alkyl (C12-15) Benzoate  
    Pentylene Glycol  
    Cyclomethicone  
    Arachidyl alcohol  
    Alcohol  
    Docosanol  
    Arachidyl glucoside  
    Cetearyl Glucoside  
    .Alpha.-Tocopherol Acetate  
    Hydroxyethyl acrylate/Sodium acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%)  
    Hydroxyethyl Cellulose (2000 MPA.S AT 1%)  
    Sodium Hydroxide  
    Aloe Vera Leaf  
    Glycine  
    Panthenol  
    Bovine Type I Collagen  
    POLYETHYLENE GLYCOL 400  
    Potassium Sorbate  
    Sodium Benzoate  
    Citric Acid Monohydrate  
    Arginine Hydrochloride  
    Leucine  
    Lysine Hydrochloride  
    Alanine  
    Sodium Lactate  
    Aspartic Acid  
    Dextrose  
    Glutamic Acid  
    Isopropyl Alcohol  
    Mannitol  
    Sorbitol  
    Tromethamine  
    Valine  
    Prezatide Copper  
    Soy Protein  
    Histidine Monohydrochloride  
    Isoleucine  
    Phenylalanine  
    Tyrosine  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0259-2202-28 1 in 1 BOX
    1 28 g in 1 TUBE
    2 NDC:0259-2202-48 1 in 1 BOX
    2 48 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 11/01/2013
    Labeler - Merz Pharmaceuticals, LLC (126209282)
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