Micuraderm

Manufacturer
Aletris Pharmaceuticals, LLC
Effective date
2023-11-07
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:54

Label at a glance#

ProductMicuraderm
Label structure8 sections

Dosage and administration

Apply Micuraderm Skin Emulsion to the affected skin areas 2 to 3 times per day (or as needed), and gently message into the skin. If the skin is broken cover Micuraderm Skin Emulsion with a dressing of choice.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For External Use Only                                                          For Topical Dematological Use Only

Rx Only                                                                                                                     60010-89072

Product Description:

DESCRIPTION SECTION

Micuraderm Skin Emulsion is an off dash white, steroid-free, fragrance-free, water-based, emulsion.

Indications for Use:

INDICATIONS & USAGE SECTION

Under the supervision of a healthcare professional, Micuraderm Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Micuraderm Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Directions for Use:

SPL UNCLASSIFIED SECTION

Apply Micuraderm Skin Emulsion to the affected skin areas 2 to 3 times per day (or as needed), and gently message into the skin. If the skin is broken cover Micuraderm Skin Emulsion with a dressing of choice.

Ingredients:

INACTIVE INGREDIENT SECTION

Micuraderm Skin Emulsion is comprised of Purified Water, lsohexadecane, Butyrospermun parkii, Pentylene glycol, Ethylhexyl palmitate, Cera Alba, PEG-30 Dipolyhydroxystearate, Bisabolol, Polyglyceryl-6 polyricinoleate, Tocopheryl acetate, Hydrogenated castor oil, Acifructol complex, Butylene glycol, Magnesium sulfate, Piroctone olamine, Allantoin, Magnesium stearate, Disodium EDTA, Vitus vinifera, Ascorbyl tetraisopalmitate, Glycyrrhetinic acid, Propyl gallate, and Telmestine.

Caution:

WARNINGS AND PRECAUTIONS SECTION

The use of Micuraderm Skin Emulsion is contraindicated in any patient with a known history of hypersensitivity to any of the ingredients. Micuraderm Skin Emulsion does not contain milk, wheat, peanut, or animal derivatives. Micuraderm Skin Emulsion does contain shea butter (Butyrospermun parkii), a derivative of shea nut oil (not peanut oil). Patients with a known allergy to nuts or nut oils should consult their physician before using this topical preparation.

How Supplied:

HOW SUPPLIED SECTION

30g Tube

To Open: Puncture seal with pointed end of cap.

Important: The opening of this product is covered with a metal seal. Do no use If seal has been punctured or is not visible.

Store at controlled room temperature 68°degrees to 77°F (20° to 25°C), excursion permitted between 59° and 86°F (15° and 30°C). Do NOT refrigerate.

Manufactured for:

Aletris Pharmaceuticals, LLC

1636n Papps Ferry Rd., Suite 218

Biloxi, MS 39532-228

(228) 207-8112

www.aletrispharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container LabelContainer Label

carton labelcarton label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86001089072Micuraderm30 g in 1 TUBE302

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.