Label: TOPCARE  CLOTRIMAZOLE 3- clotrimazole cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

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

    Active ingredients Purpose
    Clotrimazole USP 2% (100 mg in each applicatorful) Vaginal Antifungal
    Clotrimazole USP 2% (external cream) Vaginal Antifungal
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  • Use

    • treats vaginal yeast infections
    • relieves external itching and irritation due to a vaginal yeast infection
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  • Warnings

    For vaginal use only

    Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

    Ask a doctor before use if you have

    • vaginal itching and discomfort for the first time
    • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
    • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
    • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

    When using this product

    • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
    • do not have vaginal intercourse
    • mild increase in vaginal burning, itching or irritation may occur
    • if you do not get complete relief ask a doctor before using another product

    Stop use and ask a doctor if

    • symptoms do not get better in 3 days
    • symptoms last more than 7 days
    • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge

    If pregnant or breast-feeding, ask a health professional before use.

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

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  • Directions

    • before using this product read the enclosed educational brochure for complete directions and information
    • adults and children 12 years of age and over:
      • vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 3 days in a row. Throw applicator away after use.
      • external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed.
    • children under 12 years of age: ask a doctor
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  • Other information

    • To open: unscrew cap, use pointed end on cap to puncture seal
    • do not use if carton is opened
    • safety sealed: the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product.
    • store between 20° to 25°C (68° to 77°F)
    • see flap of carton or crimp of tube for lot number and expiration date
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  • Inactive ingredients

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

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  • Questions or comments?

    Call toll-free, 1-888-423-0139 for our 24 hour automated response system.

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

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  • PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

    TopCare®

    NDC 36800-062-00

    3-DAY TREATMENT

    Clotrimazole 3

    CLOTRIMAZOLE VAGINAL CREAM USP (2%)
    VAGINAL ANTIFUNGAL

    • Cures most vaginal yeast infections

    QUALITY
    GUARANTEED

    COMPARE TO
    GYNE-LOTRIMIN 3®
    active ingredients*

    One 21g (0.74 OZ) tube of three-day vaginal cream
    with three disposable applicators

    NET WT 0.74 OZ (21 g) TUBE

    Principal Display Panel - 21 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    TOPCARE   CLOTRIMAZOLE 3
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-062
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (Clotrimazole) Clotrimazole 2 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:36800-062-00 1 in 1 CARTON
    1 21 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021143 04/12/2000
    Labeler - Topco Associates LLC (006935977)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-062)
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