Label: MICONAZOLE 7- miconazole nitrate cream

  • 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 10/12

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

  • Active ingredient

    Miconazole nitrate 2% (100 mg in each applicator)

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  • Purpose

    Vaginal antifungal

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  • Uses

    treats vaginal yeast infections
    relieves external itching and irritation due to a vaginal yeast infection
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  • 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 a prescription blood thinning medicine, such as 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

    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.

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  • 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
    external cream: 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 to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.
    children under 12 years of age: ask a doctor
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  • Other information

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

    benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

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  • Principal Display Panel

    Compare to Monistat® 7 active ingredient

    MICONAZOLE 7

    MICONAZOLE NITRATE VAGINAL CREAM (2%)

    VAGINAL ANTIFUNGAL

    (MICONAZOLE NITRATE 100 mg PER APPLICATOR)

    CURES MOST VAGINAL YEAST INFECTIONS and RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

    7-DAY VAGINAL CREAM with Reusable Applicator

    Miconazole 7 Carton Image 1
    Miconazole 7 Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 7 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-110
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    PEG-5 OLEATE (UNII: 0240V77G50)  
    Product Characteristics
    Color WHITE (to off white, viscous) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-110-29 1 in 1 CARTON
    1 45 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074760 02/15/2000
    Labeler - HyVee Inc (006925671)
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