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THERA Antifungal Body (McKesson Medical-Surgical Inc.)

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POWDER 85 g in 1 BOTTLE, PLASTIC (68599-0207-3) Label Information

Complete THERA Antifungal Body Information

  • Active ingredient

    Miconazole Nitrate 2.0%


  • Purpose

    Antifungal


  • Keep out of reach of children.

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


  • Uses

    • for the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

  • Warnings

    For external use only


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

    When using this product
    • avoid contact with eyes

    Stop use and ask a doctor if
    • for athlete's foot and ringworm - irritation occurs or if there is no improvement within 4 weeks
    • for jock itch - irritation occurs or if there is no improvement within 2 weeks.

  • Directions

    • Clean the affected area and dry thoroughly
    • Apply a thin layer of the product over 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 the 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 the scalp or nails

  • Other information

    • Protect from freezing. Avoid excessive heat.

  • Inactive ingredients

    Aleurites Moluccana Seed Oil,

    Aloe Barbadensis (Aloe Vera) Leaf Juice,

    SAFFLEX TM (Consisting of:

    Calcium Pantothenate (Vitamin B 5),

    Maltodextrin, Niacinamide (Vitamin B 3),

    Pyridoxine HCl (Vitamin B 6),

    Silica,

    Sodium Ascorbyl Phosphate (Vitamin C),

    Sodium Starch Octenylsuccinate,Tocopheryl Acetate (Vitamin E)),

    Bisabolol,

    Carthamus Tinctorius (Safflower) Oleosomes,

    Lavender Ylang Fragrance,

    Nylon-12,

    Sodium Benzoate,

    Sodium Hyaluronate,

    Zea Mays (Corn) Starch,

    Zingiber Officinale (Ginger) Root Extract


  • Principal Display Panel

    NDC 68599-0207-3

    Thera

    Antifungal Body Powder

    Net Weight

    3 oz (85 g)

    MFR# 53-AFP3

    53-AFP3


  • INGREDIENTS AND APPEARANCE
    THERA ANTIFUNGAL BODY 
    miconazole nitrate powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-0207
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GINGER (UNII: C5529G5JPQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-0207-3 85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 09/01/2011
    Labeler - McKesson Medical-Surgical Inc. (023904428)