MONISTAT 7 7-DAY DISPOSABLE APPLICATORS (MICONAZOLE NITRATE) CREAM [INSIGHT PHARMACEUTICALS]

MONISTAT 7 7-DAY DISPOSABLE APPLICATORS (MICONAZOLE NITRATE) CREAM [INSIGHT PHARMACEUTICALS]
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NDC 63736-026-15
Set ID c4b68aff-e95f-47ae-b190-6a671bef1877
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number NDA017450
  • Drug Facts

  • Active ingredient

  • Purpose

    Miconazole nitrate 2% ……………….………………………………….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

    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 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.

  • Directions

    • before using this product read the enclosed consumer information leaflet for complete directions and information
    • adults and children 12 years of age and over:
      applicator: Insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use.
      ○ 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 the cream onto the 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

    • do not use if seal over tube opening has been punctured 
    • do not purchase if carton is open
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

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

  • Questions?

    If you have any questions or comments, please call 1-877-666-4782 

  • PRINCIPAL DISPLAY PANEL

    MONISTAT® 7
    Miconazole Nitrate Vaginal Cream (2%)

    Vaginal Antifungal

    Net Wt. 1.59 oz. (45g) Tube + 7 Disposable Applicators

    PRINCIPAL DISPLAY PANEL
MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%) 
Vaginal Antifungal
Net Wt. 1.59 oz. (45g) Tube + 7 Disposable Applicators

  • INGREDIENTS AND APPEARANCE
    MONISTAT 7  7-DAY DISPOSABLE APPLICATORS
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-026
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 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:63736-026-157 in 1 CARTON04/26/1993
    145 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01745004/26/1993
    Labeler - Insight Pharmaceuticals LLC (055665422)

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