Label: CLOTRIMAZOLE- clotrimazole cream

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

Drug Label Information

Updated 11/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient (in each applicatorful)

    Clotrimazole, USP 50 mg (1%)

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  • Purposes

    Vaginal antifungal/external vulvar antifungal

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  • Uses

    • treats vaginal yeast (candida) infections
    • relieves external vulvar itching and irritation associated with a yeast infection
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  • Warnings

    For vaginal or external vulvar use only

    Do not use

    • if you have abdominal pain, fever or a foul-smelling vaginal discharge. Contact your doctor immediately.
    • in children less than 12 years of age

    Ask a doctor before use if you have

    • vaginal or vulvar itching and discomfort for the first time. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this cream as directed for 7 days in a row.
    • symptoms that return within 2 months or infections that do not clear up easily with proper treatment. You could be pregnant, or there could be a serious underlying medical cause for your infections, including diabetes or a damaged immune system (including damage from infection with HIV- the virus that causes AIDS).  Please read enclosed educational pamphlet.

    When using this product

    do not use tampons

    Stop use and ask a doctor if

    symptoms do not get better in 3 days or infection isn’t gone in 7 days. You may have a condition other than a yeast infection.

    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 pamphlet
    • fill the applicator and insert one applicatorful of cream into the vagina, preferably at bedtime. Repeat this procedure 7 days in a row. Wash applicator after each use.
    • for relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching. The cream should not be used for vulvar itching due to causes other than a yeast infection.
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  • Other Information

    • store at room temperature between 2° and 30 °C (36° to 86°F)
    • see end flaps of carton and tube for lot number and expiration date
    • safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.
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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

    Well  at Walgreens
    WALGREENS PHARMACIST RECOMMENDED
    7-DAY TREATMENT
    Clotrimazole
    Vaginal Cream, USP 1%
    Vaginal Antifungal

    • Cures most vaginal yeast infections

    Educational Pamphlet Enclosed
    Compare to Gyne-Lotrimin® 7
    Vaginal Cream active ingredient

    ONE 45 g (1.5 OZ) TUBE OF VAGINAL CREAM AND 1 REUSABLE APPLICATOR (7-DAY THERAPY)

    walgreen clotrimazole label1
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  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0220
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0220-63 1 in 1 CARTON
    1 45 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074165 09/01/1998
    Labeler - Walgreen Company (008965063)
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