Label: AZOLEN- miconazole nitrate tincture 

  • NDC Code(s): 58980-818-10
  • Packager: Stratus Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Miconazole Nitrate 2%

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  • Purpose

    Topical Antifungal

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  • Uses

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

    • For external use only.

    • Do not use on children under 2 years of age except under supervision of doctor.

    • Avoid contact with eyes.

    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.

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  • 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.
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  • 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.
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  • Inactive Ingredients

    Benzyl Alcohol, Glacial Acetic Acid, Isopropyl Alcohol, Laureth-4, Purified Water and Sodium Hydroxide Solution.

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  • SPL UNCLASSIFIED SECTION

    For more information, see enclosed package insert.

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  • Questions?

    1-800-442-7882

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    STRATUS PHARMACEUTICALS INC
    12379 SW 130th Street
    Miami, Florida 33186

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  • 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
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  • INGREDIENTS AND APPEARANCE
    AZOLEN 
    miconazole nitrate tincture
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58980-818
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Benzyl Alcohol  
    Acetic Acid  
    Isopropyl Alcohol  
    Laureth-4  
    Sodium Hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-818-10 1 in 1 BOX
    1 29.57 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333C 12/01/2011
    Labeler - Stratus Pharmaceuticals, Inc. (789001641)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products Inc 104283945 MANUFACTURE(58980-818)
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