Label: CLOTRIMAZOLE cream

  • NDC Code(s): 68016-859-01
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 6, 2023

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

  • Drug Facts

  • Active ingredient

    Clotrimazole, USP 1%

  • Purpose

    Antifungal

  • Uses

    • cures 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 with 4 weeks (for athlete's foot 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

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    COMPARE TO THE ACTIVE INGREDIENT IN LOTRIMIN® AF ATHLETE'S FOOT CREAM**

    Clotrimazole Cream, USP 1%

    ANTIFUNGAL CREAM

    Proven Clinically Effective in the Treatment of the Most Athlete's Foot

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

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

  • Package label

    Clotrimazole, USP 1%

    PREMIER VALUE Antifungal Cream

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-859
    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:68016-859-011 in 1 CARTON04/30/2021
    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 DrugM00504/30/2021
    Labeler - Chain Drug Consortium, LLC (101668460)