Label: TRIPLE ANTIFUNGAL- miconazole nitrate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • For the treatment of superficial skin infections caused by yeast (Candida albicans)
    • Relieves discomfort, irrit.ation, redness and chafing associated with jock itch
    • Cures most jock itch (tinea cruris)
  • Warnings

    For external use only

    When using this productavoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks

    Do not use on childrenunder 2 years of age unless directed by a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean affected area and dry thoroughly
    • Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
    • Supervise children in the use of this product
    • Use daily for 2 weeks; If condition persists longer, consult a doctor
    • This product is not effective on the scalp or nails
  • Other information

    Store at room temperature 15°– 30°C (59°– 86°F)

  • Inactive ingredients

    White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol.

  • Questions?

    1-800-345-0032

  • SPL UNCLASSIFIED SECTION

    Distributed by Advantice Health, LLC
    Bridgewater, NJ 08807

  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

    Triple Paste AF ®

    2% MICONAZOLE NITRATE ANTIFUNGAL OINTMENT

    • Relieves burning, redness,
      irritation and discomfort
    • Unique, soothing,
      water-resistant formula
    • Lubricates skin to heal
      and prevent chafing

    Help is on the way...

    Net Wt. 2 oz (56.7 g)

    Carton

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIFUNGAL 
    miconazole nitrate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OAT (UNII: Z6J799EAJK)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-040-021 in 1 CARTON09/01/2021
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/01/2021
    Labeler - Advantice Health, LLC (192527062)
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