MONISTAT TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [INSIGHT PHARMACEUTICALS LLC]

MONISTAT TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [INSIGHT PHARMACEUTICALS LLC]
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NDC 63736-413-01
Set ID 587e42b4-cbdc-4a03-afae-f9e5e6605937
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number ANDA075915
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each applicator)

    Tioconazole 300 mg (6.5%)

  • Purpose

    Vaginal antifungal

  • Uses

    • treats vaginal yeast infections
  • 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 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 (1-800-222-1222).

  • Directions

    • before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
    • adults and children 12 years of age and over:
      ○ open the foil packet just before use and remove purple cap
      ○ insert entire content 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 get complete relief of their symptoms in just one day. Most women get some improvement in 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

  • Questions?

    1-877-666-4782

  • PRINCIPAL DISPLAY PANEL

    MONISTAT®

    Tioconazole Ointment 6.5%

    VAGINAL ANTIFUNGAL

    Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR

    PRINCIPAL DISPLAY PANEL
MONISTAT®
Tioconazole Ointment 6.5%
VAGINAL ANTIFUNGAL

Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR

  • INGREDIENTS AND APPEARANCE
    MONISTAT TIOCONAZOLE 1 
    tioconazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117) TIOCONAZOLE6.5 g  in 100 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:63736-413-011 in 1 CARTON11/21/2001
    14.6 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07591511/21/2001
    Labeler - Insight Pharmaceuticals LLC (055665422)

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