Label: FREDS MICONAZOLE 3- miconazole nitrate cream

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

Drug Label Information

Updated January 2, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Miconazole Nitrate USP 4% (200 mg in each applicatorful)

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  • Purpose

    Vaginal antifungal

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  • Use

    • treats vaginal yeast infections
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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 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.

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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:
      • 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
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  • Other information

    • store at 20°-25°C (68°-77°F)
    • do not purchase if carton is open
    • see end flaps of carton and end of tube for lot number and expiration date
    • the tube opening should be sealed. If seal has been broken, do not use product.
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  • Inactive ingredients

    cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD,
    MEMPHIS, TN 38118

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  • PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

    fred's
    Pharmacy

    Cures Most Vaginal
    Yeast Infections

    3 Day
    Treatment

    MICONAZOLE
    3
    Miconazole Nitrate Vaginal Cream USP (4%)
    (Miconazole Nitrate 200 mg per applicator)

    VAGINAL ANTIFUNGAL

    ONE 0.9 oz (25 g) TUBE OF 3 DAY VAGINAL CREAM WITH 3 DISPOSABLE APPLICATORS

    Consumer
    Information
    Leaflet Enclosed

    PRINCIPAL DISPLAY PANEL - 25 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    FREDS   MICONAZOLE 3
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-737
    Route of Administration VAGINAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    cetyl alcohol (UNII: 936JST6JCN)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    potassium hydroxide (UNII: WZH3C48M4T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-737-43 1 in 1 CARTON 12/20/2018
    1 25 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076773 03/02/2005
    Labeler - FRED'S, INC. (005866116)
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