Label: TIOCONAZOLE OINTMENT 6.5%- tioconazole ointment

  • NDC Code(s): 63094-0426-1
  • Packager: DPT Laboratories, Ltd.
  • 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 08/09

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

  • ACTIVE INGREDIENT

    Active ingredient
    (i n each applicator)
    Tioconazole 300 mg (6.5%)

    Purpose
    vaginal antifungal Close
  • Use

    • treats vaginal yeast infections
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  • Warnings

    For vaginal use only
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  • DO NOT USE

    Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Close
  • 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 human immunodeficiency virus (HIV) that causes AIDS
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  • 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 disease (STDs).
    • do not have vaginal intercourse
    • mild increase in vaginal burning, itching or irritation may occur
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  • Stop use and ask a doctor if

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

    If pregnant or breast-feeding, ask a health professional before use. Close
  • KEEP OUT OF REACH OF CHILDREN

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

    • before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
    • adults and children 12 years and over: 1.Open the foil packet just before use and remove purple cap. 2.Insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
    • children under 12 years of age: ask a doctor
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  • Other information

    • this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days.
    • if you have questions about vaginal yeast infections, consult your doctor
    • store at 20 - 25°C (68 - 77°F)
    • see end flap of carton for lot number and expiration date
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  • Inactive ingredients

    butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum Close
  • INDICATIONS & USAGE

    Do not use if sealed foil packet torn, open, or incompletely sealed.

    1-DOSE TREATMENT
    TIOCONAZOLE OINTMENT 6.5%
    VAGINAL ANTIFUNGAL

    DIRECTIONS FOR USE

    • Tear open foil packet just before using. It is best to use at bedtime.
    • Remove applicator and plunger from packet. Applicator is prefilled with vaginal ointment.
    • While firmly holding the purple-capped end of the applicator, push the tip of the plunger into the base of applicator.
    Tioconazole_oint_fig1-01

    REMOVE PURPLE CAP from top of applicator with a pull-twist action.
    Tioconazole_oint_fig2-01


    Insert the applicator

    • Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go comfortably.
    • Push the plunger into the applicator until it will go no farther. Withdraw the applicator and plunger and dispose of it in the wastebasket. Do not flush.
    • DO NOT USE TAMPONS while using this medicine. Use sanitary napkins instead.
    Tioconazole_oint_fig3-01

    PLEASE READ EDUCATIONAL BROCHURE FOR ADDITIONAL INFORMATION.

    4260000 P6

    DISTRIBUTED BY
    PERRIGO
    ALLEGAN, MI 48010 U.S.A.
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  • INGREDIENTS AND APPEARANCE
    TIOCONAZOLE  OINTMENT 6.5%
    tioconazole ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63094-0426
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TIOCONAZOLE (TIOCONAZOLE) TIOCONAZOLE 65 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE  
    MAGNESIUM ALUMINUM SILICATE  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63094-0426-1 5 g in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075915 08/22/2007
    Labeler - DPT Laboratories, Ltd. (621782218)
    Registrant - DPT Laboratories, Ltd. (621782218)
    Establishment
    Name Address ID/FEI Business Operations
    DPT Laboratories, Ltd. 621782218 manufacture
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