Label: TRIPLE ANTIFUNGAL- miconazole nitrate ointment

  • 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 14, 2021

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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 product avoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks

    Do not use on children under 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
    Cedar Knolls, NJ 07927

  • 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)

    PRINCIPAL DISPLAY PANEL - 56.7 g Tube 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 finalpart333C09/01/2021
    Labeler - Advantice Health, LLC (192527062)
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