Dermaso Plus Cream by Aletris Pharmaceuticals, LLC DERMASO PLUS CREAM-

Dermaso Plus Cream by

Drug Labeling and Warnings

Dermaso Plus Cream by is a Other medication manufactured, distributed, or labeled by Aletris Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DERMASO PLUS CREAM 
dressing, wound, drug

Product 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)