Label: RITE AID ANTIFUNGAL RINGWORM- clotrimazole cream

  • 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

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

    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
    • use daily for 4 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:
    RITE AID, 30 HUNTER LANE
    CAMP HILL, PA 17011

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  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    RITE
    AID®
    PHARMACY

    antifungal ringworm cream

    clotrimazole cream USP, 1%

    cures most ringworm
    relieves itching, redness, & irritation
    for adults & children 2 years and older

    NET WT 0.5 OZ (14.2 g)

    Principal Display Panel - 14.2 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    RITE AID   ANTIFUNGAL RINGWORM
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-1110
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (Clotrimazole) Clotrimazole 1 g  in 100 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:11822-1110-1 1 in 1 CARTON
    1 14.2 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 06/01/1995
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Taro Pharmaceuticals U.S.A., Inc (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(11822-1110)
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