Label: MYCOZYL AC- clotrimazole cream

  • 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 April 19, 2021

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

  • SPL UNCLASSIFIED SECTION

    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.

    ■ This 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, Cetyl Alcohol, Dimethicone, Disodium EDTA, DL-Alpha-Tocopheryl Acetate, 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, Sh- oligopeptide- 1, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide.

  • Mycozyl AC TM

    Manufactured in the USA by:
    PureTek Corporation
    San Fernando, CA 91340
    For questions or information
    call toll-free: 1-877-921-7873

    label

  • INGREDIENTS AND APPEARANCE
    MYCOZYL AC 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-441
    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
    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)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-441-0785 g in 1 TUBE; Type 0: Not a Combination Product04/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/06/2021
    Labeler - PureTek Corporation (785961046)