Label: CLOTRIMAZOIL ANTIFUNGAL- clotrimazole solution

  • 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 23, 2021

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

  • ClotrimazOil Antifungal Solution


  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses:

    For the cure of most:

    • athlete’s foot (tinea pedis)
    • ringworm (tinea corporis)
    • jock itch (tinea cruris)

    For relief of:


    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomforts which may accompany these conditions.
  • Warnings:

    For external use only

    Ask a doctor before use

    on children under 12 years of age

    When Using This Product

    avoid contact with eyes

    Stop Use and Ask Doctor If:

    • irritation occurs
    • there is no improvement within 4 weeks (2weeks for jock itch).

    KEEP OUT OF REACH OF CHILDREN.

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

  • Inactive Ingredients:

    Aqua (Deionized Water), BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycine Soja (Soybean) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Tocopheryl Acetate (Vitamin-E), Urea.

  • Directions:

    Read all package directions and warnings before using.

    • Use only as directed.
    • Clean the affected area with soap and warm water and dry thoroughly.
    • Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.
    • This product is not effective on the scalp or nails.
    • Avoid applying to severely cracked or irritated areas.
    • For athlete’s foot: pay special attention to spaces between 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.
    • Supervise children in the use of this product.
    • Intended for use by normally healthy adults only.
    • Persons under 12 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
  • Other Information

    Applyto skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.

    • You may report serious side effects to the phone number provided under Questions? Comments? on side panel.
  • Questions? Comments?

    Call 1-800-PEDIFIX (733-4349)

  • ClotrimazOil Antifungal Solution CLOTRIMAZOLE 1%

    Exclusive Formula

    Kills More Types of Fungus

    No Touch, No Mess Brush-on Applicator

    Manufactured in the USA for: PediFix, Inc. 301 Fields Lane Brewster, NY 10509 USA

    Lot #:

    Exp. Date:

    Item #3490 REV321 ©2021 PediFix, Inc.

    PediFix, ClotrimaZoil and the No Sore Feet Symbol are trademarks of PediFix, Inc.

  • PRINCIPAL DISPLAY PANEL

    ClotrimaZoil
    Antifungal Treatment

    1% CLOTRIMAZOLE

    First Clotrimazole & Penetrating Essential Oils Formula

    .5 Fl. oz (15 ml)

  • ClotrimazOil Antifungal Solution .5oz/15ml (68927-3490-1)

    Box

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOIL ANTIFUNGAL 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-3490
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    EMU OIL (UNII: 344821WD61)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68927-3490-11 in 1 CARTON02/07/2017
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/19/2013
    Labeler - Pedifix, Inc. (122271935)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURE SOURCE080354456manufacture(68927-3490)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEDIFIX, INC.122271935label(68927-3490)