• NDC Code(s): 51672-2003-6
  • Packager: Taro Pharmaceuticals U.S.A., Inc.

Drug Label Information

Updated January 10, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.


    Drug Facts


    Active ingredientsPurpose
    Clotrimazole USP 1% (50 mg in each applicatorful)Vaginal antifungal
    Clotrimazole USP 1% (external cream)Vaginal antifungal
  • Uses

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

  • 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
  • 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
  • Inactive ingredients

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

  • Questions or comments?

    call 1-866-923-4914


    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

    Cures Most Vaginal Yeast Infections
    7 Day Treatment

    7 Day Vaginal Cream

    Clotrimazole Vaginal Cream USP (1%)
    Vaginal Antifungal

    One 45 g (1.5 oz) Tube Of Clotrimazole Vaginal Cream USP (1%)
    & 1 Reusable Applicator

    Educational Brochure Enclosed

    Principal Display Panel
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2003
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetyl esters wax (UNII: D072FFP9GU)  
    octyldodecanol (UNII: 461N1O614Y)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    water (UNII: 059QF0KO0R)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2003-61 in 1 CARTON12/04/1995
    145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2003)