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
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- Official Label (Printer Friendly)
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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
- Contraindications
- Warnings
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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
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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 Net Weight: 450g
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INGREDIENTS AND APPEARANCE
DERMASO PLUS CREAM
dressing, wound, drugProduct Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) GS1:86001089073 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 GS1:86001089073 1 in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K150914 11/07/2023 Labeler - Aletris Pharmaceuticals, LLC (118956541)