Label: AZOLEN- miconazole nitrate liquid

  • NDC Code(s): 58980-819-60
  • 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 September 7, 2023

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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 FINALpart333C09/14/2023
    Labeler - STRATUS PHARMACEUTICALS INC (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE(58980-819)
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