AZOLEN- miconazole nitrate tincture
Stratus Pharmaceuticals, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
- Do not use on children under 2 years of age except under supervision of doctor.
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)
Stratus Pharmaceuticals, Inc.
