Loutrex
Loutrex
FULL PRESCRIBING INFORMATION: CONTENTS*
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30g topical cream carton
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 Gram Tube Label
FULL PRESCRIBING INFORMATION
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.
Uses
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, eythema, 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, Glyceryrrhetinic 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.
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, 42192-610-30. The listed product number is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
To Open: Peel foil seal away and discard.
Important: The opening of this product is covered by an aluminum seal. Do not use if seal has been broken or is not visible.
Store at controlled room temperature 68° to 77°F (20° to 25°C), excursions permitted between 59° and 86°F (15° and 30°C). Do NOT refrigerate.
Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
Manufactured for:
Acella
PHARMACEUTICALS, LLC
Alpharetta, GA 30022
1-800-541-4802
Rev. 0413
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30g topical cream carton
42192-610-30
Loutrex
Topical Cream
Rx Only
Acella
PHARMACEUTICALS, LLC
Net Wt. 30 g
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 Gram Tube Label
42192-610-30
Loutrex
Topical Cream
Rx Only
Acella
PHARMACEUTICALS, LLC
Net Wt. 30 g
Loutrex CREAM
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