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 final

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.

Drug Label Information

Updated October 19, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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.

    • 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

    For more information, see enclosed package insert.

  • Questions?

    1-800-442-7882

  • SPL UNCLASSIFIED SECTION

    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)

    Principal Display Panel - 29.57 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    AZOLEN 
    miconazole nitrate tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-818
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Acetic Acid (UNII: Q40Q9N063P)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Laureth-4 (UNII: 6HQ855798J)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-818-101 in 1 BOX09/15/2017
    129.57 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/15/2017
    Labeler - Stratus Pharmaceuticals, Inc. (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE(58980-818) , LABEL(58980-818) , PACK(58980-818)
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