Label: GOOD NEIGHBOR PHARMACY  CLOTRIMAZOLE- clotrimazole cream 

  • Label RSS
  • NDC Code(s): 24385-205-01, 24385-205-03
  • Packager: AmerisourceBergen
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Clotrimazole 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 which accompany these conditions
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  • Warnings

    For external use only

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

    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.

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  • 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
    • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change 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 persists longer, ask a doctor
    • this product is not effective on the scalp or nails
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  • Other information

    • To open: unscrew cap, use the pointed end of cap to puncture seal.
    • store between 20°- 25°C (68° - 77°F)
    • see carton or tube crimp for lot number and expiration date
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  • Inactive ingredients

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

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    Distributed By
    AmerisourceBergen
    1300 Morris Drive
    Chesterbrook, PA 19087

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    Rx

    GOOD
    NEIGHBOR
    PHARMACY®

    Compare to the active ingredient in Lotrimin® AF*

    NDC 24385-205-03

    Athlete's Foot Cream

    Clotrimazole Cream USP, 1%

    Antifungal Cream

    NET WT 1 oz (28.4 g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY   CLOTRIMAZOLE
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24385-205
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (Clotrimazole) Clotrimazole 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    benzyl alcohol  
    cetostearyl alcohol  
    cetyl esters wax  
    octyldodecanol  
    polysorbate 60  
    water  
    sorbitan monostearate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24385-205-01 1 in 1 CARTON
    1 14.2 g in 1 TUBE
    2 NDC:24385-205-03 1 in 1 CARTON
    2 28.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 08/31/1993
    Labeler - AmerisourceBergen (007914906)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(24385-205)
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