Label: TRIPLE AF- miconazole nitrate paste

  • NDC Code(s): 11086-040-01, 11086-040-02
  • Packager: Summers Laboratories 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 January 12, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    MICONAZOLE NITRATE 2%

  • PURPOSE

    PURPOSE

    ANTIFUNGAL

  • INDICATIONS & USAGE

    Uses

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

    WARNINGS

    FOR EXTERNAL USE ONLY

  • WHEN USING

    When using this product avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks
  • DO NOT USE

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    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
  • INACTIVE INGREDIENT

    Inactive ingredients

    White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol, polysorbate 80.

  • PRINCIPAL DISPLAY PANEL

    Triple Paste AF 2 oz_Unit Carton

  • INGREDIENTS AND APPEARANCE
    TRIPLE  AF
    miconazole nitrate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-040
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11086-040-0128.7 g in 1 TUBE; Type 0: Not a Combination Product10/30/2013
    2NDC:11086-040-0257 g in 1 TUBE; Type 0: Not a Combination Product10/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/30/2013
    Labeler - Summers Laboratories Inc (002382612)
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