Micuraderm by Aletris Pharmaceuticals, LLC MICURADERM-

Micuraderm by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For External Use Only                                                          For Topical Dematological Use Only

Rx Only                                                                                                                     60010-89072

Product Description:

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

Indications for Use:

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:

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:

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:

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:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MICURADERM 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	GS1:86001089072

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	GS1:86001089072	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K111168	10/28/2023

Labeler - Aletris Pharmaceuticals, LLC (118956541)