Azolen
- Dosage form
- TINCTURE
- Labeler
- Stratus Pharmaceuticals, Inc.
- Label updated
- 2025-10-30
- Retrieved
- 2026-09-07
- Active ingredients
- Miconazole Nitrate
Label information
Drug Facts
Active Ingredient
Miconazole Nitrate 2%
Purpose
Topical Antifungal
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.
Label information
- Do not use on children under 2 years of age except under supervision of doctor.
Label information
- Avoid contact with eyes.
Label information
If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor.
Label information
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.
Label information
For more information, see enclosed package insert.
Questions?
1-800-442-7882
Label information
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)
[Image in the official label — see DailyMed source]
DailyMed Set ID: 9c2574f3-3be4-405a-9c87-943dc6ef8777 · Version 4
NDC: 58980-818