Label: THERA ANTIFUNGAL BODY- miconazole nitrate powder

  • NDC Code(s): 68599-0207-3
  • Packager: McKesson Medical-Surgical 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 14, 2021

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  • 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 Juice, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Cellulose, Fragrance, Glycerin, Hydrated Silica, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Sodium Ascorbyl Phosphate (Vitamin C), Sodium Bicarbonate, Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract

  • Principal Display Panel

    NDC 68599-0207-3

    Thera

    Antifungal Body Powder

    Helps treat the most common fungal
    infections including athlete's foot,
    jock itch and ringworm.
    Single Patient Use

    Net Weight

    3 oz (85 g)

    MFR# 53-AFP3

    53-AFP3 each

  • INGREDIENTS AND APPEARANCE
    THERA ANTIFUNGAL BODY 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0207-385 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/01/2011
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0207)
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