Label: DERMASO PLUS CREAM-

  • NDC Code(s): 86001089073
  • Packager: Aletris Pharmaceuticals, LLC
  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated April 30, 2020

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

  • Indications for Use

    Under the supervision of a healthcare professional, Dermaso PlusTM Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dermaso PlusTM Cream also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

  • Device Description

    Dermaso PlusTM Cream is a non-sterile, white to off-white, low odor, fragrance free, topical product. The Dermaso PlusTM Cream forms a physical barrier that helps to maintain a moist wound and skin environment. Dermaso PlusTM Cream is a prescription device.

  • Contraindications

    Dermaso PlusTM Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

  • Warnings

    Use only as directed. Keep out of the reach of children. Avoid contact with eyes. For topical use only. Not for ophthalmic use. Do not apply within four hours prior to a radiation session.

  • Precautions and Observations

    • Dermaso PlusTM Cream does not contain a sunscreen and should not be used prior to extended exposure to the sun.
    • If clinical signs of infection are present, appropriate treatment should be initiated; use of Dermaso PlusTM Cream may be continued during the anti-infective therapy.
    • If the condition does not improve within 10-14 days, consult a physician.
    • Dermaso PlusTM Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.
  • Instructions for Use

    Dispense Dermaso PlusTM Cream into palm of hand and apply to affected area 3 times per day, or as directed by a physician. Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing. Dermaso PlusTM Cream is non-sterile.

  • Ingredients

    Water, Glycerin, Ethylhexyl Palmitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Theobroma Grandiflorum Seed Butter, Petrolatum, Dimethicone, Steareth-10, Ceteareth-10 Phosphate, Hydroxypropyl Bispalmitamide MEA (Ceramide), Tocopheryl Acetate, Methylparaben, Disodium EDTA, Propylparaben, Sodium Hyaluronate and Sodium Hydroxide.

  • How Supplied

    Dermaso PlusTM Cream is available in 450g commercial jars. 450g jar may be used for up to 60 days after opening.

    CAUTION: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.

    Store between 59°F - 86°F (15°C - 30°C).

  • Dermaso PlusTM Cream Net Weight: 450g

    Jar label

  • INGREDIENTS AND APPEARANCE
    DERMASO PLUS CREAM 
    dressing, wound, drug
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)GS1:86001089073
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1GS1:860010890731 in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK15091411/07/2023
    Labeler - Aletris Pharmaceuticals, LLC (118956541)