Label: MYCOZYL AP- miconazole nitrate powder

  • 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 11, 2023

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  • Active ingredient

    Miconazole Nitrate 2.0%

  • Purpose

    Antifungal

  • Uses

    • for the treatment of most 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

    • do not get into eyes

    Stop use and ask a doctor if

    • for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks
    • for jock itch - irritation occurs or there is no improvement within 2 weeks

    Keep out of reach of children.

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

  • 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 ■ do not use if package is damaged

  • Inactive ingredients

    Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Nylon-12, Silica, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

  • Mycozyl Antifungal Powder

    Label

  • INGREDIENTS AND APPEARANCE
    MYCOZYL AP 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENOL (UNII: 24WE03BX2T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GINGER (UNII: C5529G5JPQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NYLON-12 (UNII: 446U8J075B)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-442-0785 g in 1 BOTTLE; Type 0: Not a Combination Product12/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/08/2020
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture(59088-442) , label(59088-442)
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