Azolen™

Azolen™
SPL v4
SPL
SPL Set ID 9c2574f3-3be4-405a-9c87-943dc6ef8777
Route
TOPICAL
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Water Benzyl Alcohol Acetic Acid Isopropyl Alcohol Laureth-4 Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-15
Description

Drug Facts

Purpose

Topical Antifungal

Medication Information

Purpose

Topical Antifungal

Description

Drug Facts

Uses
  • Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • For effective relief of itchy, scaly skin between the toes.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50567-7
  • Avoid contact with eyes.
Section 50570-1
  • Do not use on children under 2 years of age except under supervision of doctor.
Warnings
  • For external use only.
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.
Questions?

1-800-442-7882

Active Ingredient

Miconazole Nitrate 2%

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.

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)

Structured Label Content

Uses
  • Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • For effective relief of itchy, scaly skin between the toes.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)
  • Avoid contact with eyes.
Section 50570-1 (50570-1)
  • Do not use on children under 2 years of age except under supervision of doctor.
Purpose

Topical Antifungal

Warnings (WARNINGS)
  • For external use only.
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.
Questions?

1-800-442-7882

Active Ingredient

Miconazole Nitrate 2%

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.

Principal Display Panel 29.57 Ml Bottle Carton (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:25.578134 · Updated: 2026-03-14T23:13:18.140905