Label: CLOTRIMAZOLE- clotrimazole cream

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

Drug Label Information

Updated December 13, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Clotrimazole, USP 1% (50 mg in each applicatorful)
    Clotrimazole, USP 1% (external cream)

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  • Purposes

    Vaginal antifungal
    Vaginal antifungal

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  • Uses

    • 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.

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 7 days in a row. Wash applicator after each 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

    • 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
    • Tamper-evident: 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

    Image1
    WALGREENS PHARMACIST RECOMMENDED‡ 

    NDC 0363-0220-63
    Clotrimazole 7
    Vaginal Cream, USP 1% 
    Vaginal Antifungal
    7-Day Treatment
    Cures most vaginal yeast infections
    Educational Pamphlet Enclosed
    Compare to Gyne-Lotrimin® 7 Vaginal Cream active ingredient‡‡

    ONE 1.5 OZ (45 g) Tube of Vaginal Cream (1%) & 1 Reusable Applicator (7-Day therapy)

    Clotrimazole 7
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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
    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)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    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 09/01/1998
    1 45 g in 1 TUBE; Type 0: Not a Combination Product
    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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