Loutrex by Avion Pharmaceuticals, LLC LOUTREX- cream

Loutrex by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Topical Cream

For Topical Dermatological Use Only       Rx only
For External Use Only

SPL UNCLASSIFIED SECTION

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

INDICATIONS & USAGE

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

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

INSTRUCTIONS FOR USE

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.

INACTIVE INGREDIENT

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

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

How Supplied: 30 g tube, 75854-0103-30 and in a 2 g sample packette, 75854-0103-02.

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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.

STORAGE AND HANDLING

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.

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Marketed by:

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

Rev 0115-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30g topical cream carton

Rx Only         75854-0103-30

Loutrex
Topical Cream

Avion
PHARMACEUTICALS

Net Wt. 30 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 Gram Tube Label

Rx Only         75854-0103-30

Loutrex
Topical Cream

Net Wt. 30 g

Avion
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

LOUTREX 
dressing, wound, drug cream

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:75854-103
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	WHITE WAX (UNII: 7G1J5DA97F)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	PUMMELO (UNII: ET1TN5W71X)
INGR	LEMON (UNII: 24RS0A988O)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	ENOXOLONE (UNII: P540XA09DR)
INGR	HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
INGR	ISOHEXADECANE (UNII: 918X1OUF1E)
INGR	MAGNESIUM STEARATE (UNII: 70097M6I30)
INGR	MAGNESIUM SULFATE (UNII: DE08037SAB)
INGR	PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	PIROCTONE OLAMINE (UNII: A4V5C6R9FB)
INGR	POLYGLYCEROL POLYRICINOLEIC ACID (UNII: 3C96Y1D5T4)
INGR	PROPYL GALLATE (UNII: 8D4SNN7V92)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	WATER (UNII: 059QF0KO0R)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	WINE GRAPE (UNII: 3GOV20705G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:75854-103-30	1 in 1 CARTON
1		30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K120730	12/03/2014

Labeler - Avion Pharmaceuticals, LLC (965450542)