Azolen

Stratus Pharmaceuticals, Inc.

AZOLEN™ TINCTURE

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient
• Purpose
• Azolen Uses
• WARNINGS
• Directions
• Other Information
• Inactive Ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Purpose

Topical Antifungal

Azolen Uses

• Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• For effective relief of itchy, scaly skin between the toes.

WARNINGS

• For external use only.

• Do not use on children under 2 years of age except under supervision of doctor.

• Avoid contact with eyes.

If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor.

Keep out of the reach of children. If swallowed, get medical help or contact poison control center immediately.

Directions

• Clean and dry the affected area.
• Cover the affected area with a thin layer twice a day (a.m. and p.m.) on skin, under nails and surrounding cuticle areas.
• Supervise children in the use of this product.
• For athlete's foot and ringworm use daily for four (4) weeks.
• This product is not effective on scalp or nails.

Other Information

• Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature.

Inactive Ingredients

Benzyl Alcohol, Glacial Acetic Acid, Isopropyl Alcohol, Laureth-4, Purified Water and Sodium Hydroxide Solution.

For more information, see enclosed package insert.

Questions?

1-800-442-7882

Distributed by:
STRATUS PHARMACEUTICALS INC
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Carton

NDC 58980-818-10

AZOLEN™
TINCTURE

(MICONAZOLE NITRATE USP, 2%)

TOPICAL ANTIFUNGAL

Distributed by:
STRATUS

NET VOL.: 1.0 FL OZ (29.57 mL)