MONISTAT 3 3-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) CREAM [INSIGHT PHARMACEUTICALS]

MONISTAT 3 3-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) CREAM [INSIGHT PHARMACEUTICALS]
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NDC 63736-015-18
Set ID f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number NDA020827
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole nitrate 4% (200 mg in each applicatorful)

  • Purpose

    Vaginal antifungal

  • Use

    • 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 human immunodeficiency virus (HIV) that causes AIDS

    Ask a doctor or pharmacist before use if you are

    taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

    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
    • 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 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

    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 consumer information leaflet for complete directions and information
    • adults and children 12 years and over:
      • applicators: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.

    • children under 12 years of age: ask a doctor
  • Other information

    • do not use if printed applicator wrapper is torn, open or incompletely sealed
    • do not purchase if carton is open
    • store at 20° - 25°C (68° to 77°F)
  • Inactive ingredients

    benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

  • Questions?

    Call toll-free 877-666-4782 or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

    3 DAY TREATMENT • CREAM

    MONISTAT® 3
    Miconazole Nitrate Vaginal Cream (4%)
    (Miconazole Nitrate 200 mg per applicator)
    VAGINAL ANTIFUNGAL

    Net Wt. 0.18 oz. (5g) each applicator

    3 DAY TREATMENT • CREAM
MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)
(Miconazole Nitrate 200 mg per applicator)
VAGINAL ANTIFUNGAL
Net Wt. 0.18 oz. (5g) each applicator

  • INGREDIENTS AND APPEARANCE
    MONISTAT 3  3-DAY PRE-FILLED APPLICATORS
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-015
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-015-183 in 1 CARTON03/30/1998
    15 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02082703/30/1998
    Labeler - Insight Pharmaceuticals LLC (055665422)

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