Label: CLOTRIMAZOLE cream

  • NDC Code(s): 36800-508-01
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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

  • Drug Facts

  • Active ingredients

    Clotrimazole, USP 1%

    )

  • Purpose

    Antifungal

  • Uses

    • treats most athlete's foot, jock itch, and ringworm
    • relieves itching, burning, cracking, scaling, and discomfort
  • Warnings

    For external use only

    Do not use

    on children under 2 years of age, unless directed by a doctor.

    When using this product,

    avoid contact with the eyes.

    Stop use and ask a doctor if

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

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • wash 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, 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
    • if condition lasts longer, contact a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • store at room temperature 20º-25ºC (68º-77ºF)
    • before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredients

    benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

  • Question or comments?

    Call toll free 1-888-423-0139

  • Principal display panel

    COMPARE TO LOTRIMIN® AF ATHLETE'S FPPT CREAM ACTIVE INGREDIENT*

    Athlete's Foot Cream

    Cure Most Athlete's Foot

    RELIEVES:

    • Itching
    • Burning
    • Cracking
    • Scaling
    • Proven Clinically Effective in the Treatment of Most Athlete's Foot
    • Soothes Itching and Burning

    NET WT. OZ (g)

    *This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Lotrimin® AF Athlete's Foot Cream.

    DISTRIBUTED BY

    TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    www.topcarebrand.com

  • Package label

    Clotrimazole, USP 1%

    TOPCARE HEALTH Athlete's Foot Cream

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-508
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-508-011 in 1 CARTON09/30/202105/30/2026
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/30/202105/30/2026
    Labeler - TOP CARE (Topco Associates LLC) (006935977)