TRIPLE AF (MICONAZOLE NITRATE) PASTE [SUMMERS LABORATORIES INC]

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TRIPLE AF (MICONAZOLE NITRATE) PASTE [SUMMERS LABORATORIES INC]
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NDC 11086-040-01, 11086-040-05, 11086-040-11, 11086-040-15
Set ID 8d19b86d-b63c-485f-b143-2bc35f76c659
Category HUMAN OTC DRUG LABEL
Packager Summers Laboratories Inc
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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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