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 Item Code (Source) NDC:0259-2202
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Onion (UNII: 492225Q21H)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Arachidyl alcohol (UNII: 1QR1QRA9BU)  
    Alcohol (UNII: 3K9958V90M)  
    Docosanol (UNII: 9G1OE216XY)  
    Arachidyl glucoside (UNII: 6JVW35JOOJ)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Hydroxyethyl acrylate/Sodium acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    Hydroxyethyl Cellulose (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Glycine (UNII: TE7660XO1C)  
    Panthenol (UNII: WV9CM0O67Z)  
    Bovine Type I Collagen (UNII: FHJ3ATL51C)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Arginine Hydrochloride (UNII: F7LTH1E20Y)  
    Leucine (UNII: GMW67QNF9C)  
    Lysine Hydrochloride (UNII: JNJ23Q2COM)  
    Alanine (UNII: OF5P57N2ZX)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Aspartic Acid (UNII: 30KYC7MIAI)  
    Dextrose (UNII: IY9XDZ35W2)  
    Glutamic Acid (UNII: 3KX376GY7L)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Mannitol (UNII: 3OWL53L36A)  
    Sorbitol (UNII: 506T60A25R)  
    Tromethamine (UNII: 023C2WHX2V)  
    Valine (UNII: HG18B9YRS7)  
    Prezatide Copper (UNII: 6BJQ43T1I9)  
    Soy Protein (UNII: R44IWB3RN5)  
    Histidine Monohydrochloride (UNII: 1D5Q932XM6)  
    Isoleucine (UNII: 04Y7590D77)  
    Phenylalanine (UNII: 47E5O17Y3R)  
    Tyrosine (UNII: 42HK56048U)  
    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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