Label: CLOTRIMAZOLE solution

  • NDC Code(s): 70010-229-54
  • Packager: Granules Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 24, 2024

If you are a consumer or patient 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.

  • 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.

    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 between 15º-30ºC (59º-86ºF)
  • Inactive ingredient

    polyethylene glycol

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • PRINCIPAL DISPLAY PANEL - Container Label

    NDC 70010- 229-54

    Clotrimazole
    (Topical Solution), USP

    1%

    Antifungal

    For External use only,

    not for Opthalmic use.

    Keep this and all medications out

    of the reach of children.

    10 mL (1/3 fl oz)

    clotrima-container

  • PRINCIPAL DISPLAY PANEL - Container Carton Label

    NDC 70010- 229-54

    *Compare to the active ingredient in

    Lotrimin ® AF

    Athlete's Foot Solution

    Clotrimazole

    (Topical Solution),

    USP

    1%

    Antifungal

    • Relieves Itching & Burning

    • Greaseless, Nonstanining

    For External use only,

    Not for Ophthalmic use.

    Keep this and all medications

    out of the reach of children.

    10 mL (1/3 fl oz)

    clotrima-carton

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70010-229
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70010-229-5410 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/22/2023
    Labeler - Granules Pharmaceuticals Inc. (079825711)