AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]

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AZOLEN (MICONAZOLE NITRATE) TINCTURE [STRATUS PHARMACEUTICALS, INC.]
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NDC 58980-818-10
Set ID 9c2574f3-3be4-405a-9c87-943dc6ef8777
Category HUMAN OTC DRUG LABEL
Packager Stratus Pharmaceuticals, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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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