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 December 2, 2016

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

  • Drug Facts
  • Active ingredient

    Clotrimazole, USP 1%

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  • Purpose

    Antifungal

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  • Uses

    • cures most athlete’s foot, jock itch, and ringworm   • relieves itching, burning, cracking, scaling, and discomfort

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  • Warnings

    For external use only

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  • Do not use

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

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  • When using this product

    • avoid contact with the eyes

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  • 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)

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  • 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
    • 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
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  • Other information

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

    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
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  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE  ANTIFUNGAL
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-0350
    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:0472-0350-56 1 in 1 CARTON 12/01/2016
    1 28 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 12/01/2016
    Labeler - Actavis Pharma, Inc. (119723554)
    Establishment
    Name Address ID/FEI Business Operations
    Encube Ethicals Pvt. Ltd 725076298 ANALYSIS(0472-0350) , LABEL(0472-0350) , MANUFACTURE(0472-0350) , PACK(0472-0350)
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