Label: MICOMITIN ANTIFUNGAL- clotrimazole cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 14, 2022

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

  • Drug Facts

    Drug Facts

    Active ingredient

    Clotrimazole 1%

    Purpose

    Antifungal

  • Uses

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

  • Warnings

    For external use only.

    When using this product avoid contact with eyes

    Do not use

    • on children under 2 years of age unless directed by a doctor
    • for athlete's foot and ringworm - if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor
    • for jock itch - if irritation occurs or if there is no improvement in 2 weeks, 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 the 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.
    • his product is not effective on the scalp or nails.

    Use under the direction of a medical practitioner

  • Other information

    ■ Store at 15° - 30°C (59° - 86°F) ■ avoid excessive heat ■ do not use if package is damaged

  • Inactive ingredients

    Aqua (Purified Water), Beta-Glucan, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glycine Soja (Soybean) Oil, 1,2-Hexanediol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Panthenol, PEG-100 Stearate, PEG-40 Stearate PEG-8, Polysorbate 60, Propylene Glycol, Sholigopeptide-1, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, DL-Alpha-Tocopheryl Acetate

  • Micomitin™ Antifungal Cream

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

    label

  • INGREDIENTS AND APPEARANCE
    MICOMITIN ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-642
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    NEPIDERMIN (UNII: TZK30RF92W)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CURDLAN (UNII: 6930DL209R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-642-0785 g in 1 TUBE; Type 0: Not a Combination Product04/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/19/2022
    Labeler - PureTek Corporation (785961046)