Topical Cream

For Topical Dermatological Use Only       Rx only
For External Use Only

Product Description: Loutrex™ Topical Cream is an off-white, steroid-free, fragrance-free, water-based emulsion.

Indications for Use: Under the supervision of a healthcare professional, Loutrex™ Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Loutrex™ Topical Cream helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Contraindications: The use of Loutrex™ Topical Cream is contraindicated in any patient with a known hypersensitivity to any of the ingredients.

Directions for Use: Apply Loutrex™ Topical Cream to the affected skin areas 2 or 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover Loutrex™ Topical Cream with a dressing of choice.

Ingredients: Loutrex™ Topical Cream is comprised of Allantoin, Ascorbyl Tetraisopalmitate, Bisabolol, Butylene Glycol, Butyrospermum Parkii, Cera Alba, Citric Acid, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycyrrhetinic Acid, Hydrogenated Castor Oil, Isohexadecane, Magnesium Stearate, Magnesium Sulfate, PEG-30 Dipolyhydroxystearate, Pentylene Glycol, Piroctone Olamine, Polyglyceryl-6 Polyricinoleate, Propyl Gallate, Propylene Glycol, Purified Water, Tocopheryl Acetate and Vitis Vinifera (Grape) Fruit Extract.

Precautions: Loutrex™ Topical Cream does not contain milk, wheat, peanut or animal derivatives. Loutrex™ Topical Cream does contain shea butter (Butyrospermum 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: 30 g tube, 75854-0103-30 and in a 2 g sample packette, 75854-0103-02.

To Open: Tube: Peel foil seal away and discard. Sample packette: Tear open at the notch.

Important: The opening of this product is covered by an aluminum seal (Tube only - 75854-0103-30). Do not use if seal has been broken or is not visible.

Store at 20° - 25°C (68° - 77°F), excursions permitted between 15° - 30°C (59° - 86°F). [See USP, “Controlled Room Temperature”].

DO NOT REFRIGERATE. PROTECT FROM FREEZING AND EXCESSIVE HEAT.

Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner.

Marketed by:

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
1-888-61-AVION

Rev 0115-01

Rx Only         75854-0103-30

Loutrex
Topical Cream

Avion
PHARMACEUTICALS

Net Wt. 30 g

Rx Only         75854-0103-30

Loutrex
Topical Cream

Net Wt. 30 g

Avion
PHARMACEUTICALS