Label: FUNGAZOIL ADVANCED- clotrimazole 1% 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 June 12, 2014

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

  • 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 as doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)

    If swallowed, get medical help or contact a Poison control center immediately.

  • Active Ingredient

    Clotrimazole 1%

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • 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.

  • 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.
    • Super vise 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.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FUNGAZOIL ADVANCED 
    clotrimazole 1% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-3492
    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
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    EMU OIL (UNII: 344821WD61)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68927-3492-115 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/15/2014
    Labeler - Pedifix (122271935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source969241041manufacture(68927-3492)