MICONAZOLE NITRATE CREAM [FRED'S, INC.]

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MICONAZOLE NITRATE CREAM [FRED'S, INC.]
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NDC 55315-815-63
Set ID d91714a5-20a6-4f0b-ba97-5c9e5f0dfc22
Category HUMAN OTC DRUG LABEL
Packager FRED'S, INC.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number ANDA074444
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole Nitrate USP 2% (100 mg in each applicatorful)

  • Purpose

    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:
      • applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after each 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 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
  • Other information

    • do not purchase if carton is opened
    • do not use if seal over tube opening has been punctured or is not visible
      To open: unscrew cap, use pointed end on cap to puncture seal
      To close: screw cap back onto the tube
    • store at 20°-25°C (68°-77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

    fred's
    Pharmacy

    Cures Most Vaginal
    Yeast Infections

    7 Day
    Treatment

    7 DAY VAGINAL CREAM
    Miconazole Nitrate Vaginal Cream USP (2%)
    (Miconazole Nitrate 100 mg per application)

    VAGINAL ANTIFUNGAL

    Educational Brochure Enclosed

    One 45 g (1.5 oz) Tube Of Miconazole Nitrate Vaginal Cream USP (2%) & 7 Disposable Applicators

    Principal Display Panel - 45 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-815
    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
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Water (UNII: 059QF0KO0R)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-815-631 in 1 CARTON02/14/2019
    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
    ANDAANDA07444401/13/1997
    Labeler - FRED'S, INC. (005866116)
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