Label: MICONATATE- miconazole nitrate and tolnaftate kit

  • NDC Code(s): 59088-442-07, 59088-443-03, 59088-778-00
  • Packager: PureTek Corporation
  • 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

If you are a consumer or patient please visit this version.

  • Mycozyl AP

  • Active ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
    • relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.
  • 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.

  • Mycozylal AL

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
    • relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.
    • for the prevention of most Athlete’s foot with daily use.
    • eliminates fungus on fingers, toes, and around the nails.
    • eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.
  • 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

    • for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
    • for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor
  • 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) paying special attention to the edges of the nail, cuticles, and skin around the nails 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
    • if condition persists longer, consult a doctor.

    Use under the direction of a medical practitioner

  • Other information

    • Store at 15 - 30°C (59° - 86°F) [see USP Controlled Room Temperature].
    • avoid excessive heat
    • do not use if package is damaged
  • How Supplied

    Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)

  • Inactive ingredients

    Apple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

  • Miconatate™

    Packaged in the USA by:
    PureTek Corporation
    Panorama City, CA 91402
    For questions or information
    call toll-free: 877-921-7873

    Label

  • INGREDIENTS AND APPEARANCE
    MICONATATE 
    miconazole nitrate and tolnaftate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-778
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-778-001 in 1 CARTON; Type 0: Not a Combination Product09/02/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE, WITH APPLICATOR 1 mL  in 30 
    Part 20 BOTTLE 1 g  in 85 
    Part 1 of 2
    MYCOZYL AL 
    tolnaftate liquid
    Product Information
    Item Code (Source)NDC:59088-443
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.3 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
    LAURETH-4 (UNII: 6HQ855798J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-443-0330 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/09/2021
    Part 2 of 2
    MYCOZYL AP 
    miconazole nitrate powder
    Product Information
    Item 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)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GINGER (UNII: C5529G5JPQ)  
    CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NYLON-12 (UNII: 446U8J075B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-442-0785 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/02/2021
    Labeler - PureTek Corporation (785961046)