FDA Label for Azolen
View Indications, Usage & Precautions
Azolen Product Label
The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
For more information, see enclosed package insert.
Distributed by:
STRATUS PHARMACEUTICALS INC
12379 SW 130th Street
Miami, Florida 33186
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.
Otc - Do Not Use
- Do not use on children under 2 years of age except under supervision of doctor.
Otc - When Using
- Avoid contact with eyes.
Otc - Stop Use
If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor.
Otc - Keep Out Of Reach Of Children
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.
Questions?
1-800-442-7882
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)
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