Label: CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream

  • 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 November 19, 2019

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, 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 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 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 last longer, contact a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • Store between 2o-30oC (36o – 86oF).  • 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?

    1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

  • Principal Display Panel

    Actavis
    NDC 0472-0350-56
    Compare to the active ingredient in Lotrimin® AF* 

    Clotrimazole Cream, USP 1%
    Antifungal
    Cures Most Athlete’s Foot
    Relieves: Itching │ Burning │ Cracking │ Scaling 

    Net wt. 1 oz (28 g)

    Clotrimazole Cream
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE  ANTIFUNGAL
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0350
    Route of AdministrationTOPICAL
    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, ANHYDROUS (UNII: KH7I04HPUU)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0472-0350-561 in 1 CARTON01/03/2017
    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 FINALpart333C01/03/2017
    Labeler - Actavis Pharma, Inc. (119723554)