Label: MEDERMA STRETCH MARKS THERAPY- dimethicone cream

  • NDC Code(s): 0259-2102-05, 0259-2102-15
  • Packager: Merz Pharmaceuticals, LLC
  • 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 February 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Dimethicone 2%

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects and helps relieve chapped or cracked skin
  • 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

    If pregnant or breastfeeding, ask a health professional before use

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

  • Directions

    Apply as needed

  • Other Information

    Store at room temperature

  • Inactive Ingredients

    Water, Allium Cepae (Onion) Bulb Extract, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Glycerin, Pentylene Glycol, Cyclomethicone, Arachidyl Alcohol, Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ethoxydiglycol, Cetearyl Glucoside, Tocopheryl Acetate, Fragrance, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Disodium EDTA, Centella Asiatica Leaf Extract, Hydrolyzed Collagen, Hydrolyzed Soy Protein, Sodium Hydroxide, Iron Oxides.

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 150 g Tube Box

    MEDERMA®

    stretch
    marks
    therapy

    Improve appearance
    Reduce discoloration
    Smooth texture
    Enhance softness

    Hydrates
    to
    HELP
    PREVENT
    stretch
    marks

    DERMATOLOGIST
    RECOMMENDED

    Clinically shown to
    produce noticeable
    improvement in
    just 4 weeks

    PARABEN FREE
    intensive cream
    and skin protectant

    NET WT. 5.29 OZ. (150g)

    PRINCIPAL DISPLAY PANEL - 150 g Tube Box
  • INGREDIENTS AND APPEARANCE
    MEDERMA STRETCH MARKS THERAPY 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0259-2102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O) dimethicone20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    Docosanol (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ONION (UNII: 492225Q21H)  
    Glycerin (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0259-2102-151 in 1 BOX12/01/201306/30/2024
    1150 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0259-2102-050.5 g in 1 PACKET; Type 0: Not a Combination Product12/01/201306/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/01/201306/30/2024
    Labeler - Merz Pharmaceuticals, LLC (126209282)
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