Label: CLOTRIMAZOLE- clotrimazole cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated 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 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 LABEL Item Code (Source) NDC:0363-0220
    Route of Administration VAGINAL 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  
    OCTYLDODECYL STEARATE  
    POLYSORBATE 60  
    WATER  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    SORBITAN MONOSTEARATE  
    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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