Label: AZOLEN- miconazole nitrate liquid

  • NDC Code(s): 58980-819-60
  • Packager: STRATUS PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Miconazole Nitrate 2%

  • Purpose

    Topical Antifungal

  • Uses

    • For the treatment of most:
      • athlete's foot
      • jock itch
      • ringworm
    • Relieves:
      • itching
      • scaling
      • cracking
      • burning
      • redness
      • discomfort
  • Warnings

    for external use only

    Do not use

    • on children under 2 years of age unless directed by a doctor
    • for diaper rash

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks (for jock itch)
    • there is no improvement within 4 weeks (for athlete's foot and ringworm)

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately

  • Directions

    • Wash the affected area well with AZOLEN Anti-Fungal Wash and let product sit 1-2 minutes before rinsing
    • Dry the affected area thoroughly
    • Apply the product over the affected area twice daily (morning and night) or as directed by a doctor
    • Supervise children in the use of this product
    • For athlete's foot: Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
    • For athlete's foot and ringworm, use daily for 4 weeks
    • For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor
    • This product is not effective on scalp or nails
  • Other Information

    • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature]
  • Inactive Ingredients

    Lauramidopropyl Betaine, Laureth-7, Panthenol, Phospholipid EFA, Purified Water, Sodium Chloride, Sodium C14-16 Olefin Sulfonate, Tea Tree Oil.

  • Questions or Comments?

    Call us at 1-800-442-7882

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Stratus Pharmaceuticals Inc.
    Miami, FL 33186

  • PRINCIPAL DISPLAY PANEL - 170 g Bottle Box

    NDC 58980-819-60

    AZOLEN™
    ANTI-FUNGAL WASH

    (MICONAZOLE NITRATE 2%)

    NOW TREAT
    JOCK ITCH IN
    THE SHOWER

    SOOTHES AND
    CONTROLS MOST:*
    JOCK ITCH
    ATHLETE'S FOOT
    RINGWORM

    STRATUS
    PHARMACEUTICALS INC

    Net Wt 6 oz (170 g)

    Principal Display Panel - 170 g Bottle Box
  • INGREDIENTS AND APPEARANCE
    AZOLEN 
    miconazole nitrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-819
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-819-601 in 1 BOX09/14/2023
    1170 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/14/2023
    Labeler - STRATUS PHARMACEUTICALS INC (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE(58980-819)
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