Label: RINGWORM- 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 April 6, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most ringworm
    • relieves itching, redness, irritation and discomfort which accompany this condition
  • Warnings

    For external use only

    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

    Do not use on children under 2 years of age unless directed by a doctor.

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

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in the use of this product
    • use daily for 4 weeks
    • if condition persists longer, ask a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
    • to open: unscrew cap, use the pointed end of cap to puncture seal.
    • store between 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    Walgreens

    Ringworm Cream

    CLOTRIMAZOLE CREAM USP, 1%
    ANTIFUNGAL
    NET WT 0.5 OZ (14.2 g)

    PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    RINGWORM 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2107
    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)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2107-011 in 1 CARTON04/02/2021
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C04/02/2021
    Labeler - Walgreen Company (008965063)