Label: CLOTRIMAZOLE solution

  • NDC Code(s): 68784-301-01, 68784-301-10
  • Packager: ACINO PRODUCTS LIMITED LIABILITY COMPANY
  • Category: HUMAN OTC DRUG LABEL

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 19, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    CLOTRIMAZOLE USP, 1%

  • PURPOSE

    ANTIFUNGAL

  • USES

    Cures most

    • Athlete's foot (tinea pedis)
    • Jock Itch (tinea cruris)
    • Ringworm (tinea corporis)

    Effectively relieves
    • Itching
    • Cracking
    • Burning
    • Discomfort which can accompany these conditions
    • This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product.
    For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily.

  • 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 a doctor if
    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product.

    For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily.

  • OTHER INFORMATION

    Store at 15° to 30°C (59° to 86°F)

  • INACTIVE INGREDIENT

    polyethylene glycol 400

  • QUESTIONS

    call 1-877-227-2594

  • PRINCIPAL DISPLAY PANEL

    ACINO_clotrimazole carton 10mLCP

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68784-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68784-301-101 in 1 BOX07/29/2019
    1NDC:68784-301-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/29/2019
    Labeler - ACINO PRODUCTS LIMITED LIABILITY COMPANY (019385518)
    Establishment
    NameAddressID/FEIBusiness Operations
    ACINO PRODUCTS LIMITED LIABILITY COMPANY019385518manufacture(68784-301)