Label: TIOCONAZOLE OINTMENT 6.5%- tioconazole ointment

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

Drug Label Information

Updated August 31, 2009

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  • ACTIVE INGREDIENT

    Active ingredient
    (in each applicator)
    Tioconazole 300 mg (6.5%)

    Purpose
    vaginal antifungal
  • Use

    • treats vaginal yeast infections
  • Warnings

    For vaginal use only
  • DO NOT USE

    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 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 disease (STDs).
    • do not have vaginal intercourse
    • mild increase in vaginal burning, itching or irritation may occur
  • 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
  • PREGNANCY OR BREAST FEEDING

    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 right away.
  • 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
  • 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
  • Inactive ingredients

    butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum
  • 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.
  • INGREDIENTS AND APPEARANCE
    TIOCONAZOLE  OINTMENT 6.5%
    tioconazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63094-0426
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117) TIOCONAZOLE65 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63094-0426-15 g in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07591508/22/2007
    Labeler - DPT Laboratories, Ltd. (621782218)
    Registrant - DPT Laboratories, Ltd. (621782218)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT Laboratories, Ltd. 621782218manufacture
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