Label: SMOOTH GATOR FUNGUS ELIMINATOR- clotrimazole liquid

  • 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 February 7, 2017

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

  • DRUG FACTS

  • Active ingredients:

    Clotrimazole 1.00%

    Purpose:

    Antifungal Treatment

  • 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 2 years of age.

    When using this product

    • avoid contact with eyes.

    Stop use and ask doctor if

    Irritation occurs or there is no improvement within 4 weeks (2 weeks for jock itch).

    KEEP OUT OF RICH OF CHILDREN.

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

  • 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.
    • 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 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.

  • Other information:

    Apply to 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.

  • Inactive ingredients:

    BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus(Eucalyptus) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).

  • Package Labeling:

    label

  • INGREDIENTS AND APPEARANCE
    SMOOTH GATOR FUNGUS ELIMINATOR 
    clotrimazole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70673-747
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    EMU OIL (UNII: 344821WD61)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70673-747-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/29/2016
    Labeler - Smooth Gator, LLC (029819479)