Label: 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 December 5, 2017

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  • Drug Facts
  • Active ingredient

    Clotrimazole, USP 1%

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  • Purpose

    Antifungal

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  • Uses

    • cures most jock itch • relieves itching, burning, scaling, discomfort, and chafing associated with jock itch

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  • 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 2 weeks

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

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  • 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
    • use daily for 2 weeks
    • if condition lasts longer, ask a doctor
    • this product is not effective on the scalp or nails

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  • Other Information

    • Store between 2°-30°C (36°-86°F). 
    • Before using any medication, read all label directions   • Keep carton, it contains important information

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  • Inactive ingredients

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

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  • Questions?

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

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  • Principal Display Panel

    NDC 11822-0351-3
    *Compare to the active ingredient in Lotrimin® AF
    antifungal cream
    clotrimazole cream, USP 1%
    cures most jock itch
    relieves itching, burning,
    scaling and chafing 

    NET WT 0.5 OZ (14 g)

    Antifungal Cream
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  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0351
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0351-3 1 in 1 CARTON 04/15/2011
    1 14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 04/15/2011
    Labeler - Rite Aid (014578892)
    Registrant - Teva Pharmaceuticals USA, Inc. (001627975)
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