Label: 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 November 2, 2019

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

  • ACTIVE INGREDIENT

    clotrimazole 1%

  • 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, there is no improvement within 4 weeks (2 weeks for jock itch)

  • PURPOSE

    Antifungal

  • DOSAGE & ADMINISTRATION

    • 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-fit- ting, 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.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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

  • INACTIVE INGREDIENT

    Aqua (Deionized Water), BHT, Car thamus Tinctorius (Saf flower) 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, Tocopher yl Acetate (Vitamin- E), Urea.

  • INDICATIONS & USAGE

    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.

  • PRINCIPAL DISPLAY PANEL

    labellabelbox

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3492
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82)  
    EMU OIL (UNII: 344821WD61)  
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    UREA (UNII: 8W8T17847W)  
    EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)  
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3492-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/01/2015
    Labeler - Walgreens (008965063)
    Registrant - walgreens (008965063)