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 May 7, 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 ask 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, BHT, safflower oil, emu oil, eucalyptus globlus oil, soybean oil, lavender oil, tea tree oil, peppermint oil, olive fruit oil, sweet almond oil, rose hip oil, jojoba oil, vitamin E, urea

  • Purpose

    Anti-fungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    Read all package directions and warnings before using:
    Use only as directed
    Clean the affected area with soap and warm water and dry throughly
    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 severly cracked or irritated areas
    For athlete's foot pay special attention to spaces between toes, wear well-fitting vetilated 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 foruse by normally healthy adults only
    Persons under 18 years of age or thoes with sensitive or allergic skin should use only as directed by a doctor.

  • Other information

    Apply to skin around affected areas. While not allfinger and toe fungal infections are curabel with OTC topical medications. If you see improvement whithin 4 weeks of use, you may continue to use until satisfactory results are obtained.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-3491
    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)  
    CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)  
    EMU OIL (UNII: 344821WD61)  
    EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    UREA (UNII: 8W8T17847W)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68927-3491-115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/05/2014
    Labeler - Pedifix (122271935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source969241041manufacture(68927-3491)