Azolen Tincture
FDA Label NDC 58980-818

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals, Inc. for the product Azolen (NDC 58980-818). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (29.57 mL Bottle Carton)

Principal Display Panel (29.57 mL Bottle Carton)

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