Label: MICONAZOLE NITRATE- miconazole nitrate suppository 

  • Label RSS
  • 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 09/12

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

  • OTC - ACTIVE INGREDIENT SECTION

    Miconazole nitrate 100 mg

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  • OTC - PURPOSE SECTION

    Vaginal Antifungal

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  • INDICATIONS & USAGE SECTION

    Use
    • treats vaginal yeast infections

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  • WARNINGS SECTION

    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
    • 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 by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).
    • do not have vaginal intercourse

    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, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
    • In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

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  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a health professional before use

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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION SECTION

    Directions
    • before using this product, read the enclosed brochure for complete instructions
    • adults and children 12 years of age and over:
          • insert 1 suppository into the vagina at bedtime for 7 nights in a row  
          • wash applicator after each use
    • children under 12 years of age: ask a doctor

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  • STORAGE AND HANDLING SECTION

    • store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F).
    • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)

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  • INACTIVE INGREDIENT SECTION

    hydrogenated vegetable oil base

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  • OTC - QUESTIONS SECTION

    QUESTION?
    call 1-800-922-1038

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Miconazole Nitrate Vaginal Suppositories USP, 100 mg

    NDC 42254-295-07

    7 Day Treatment
    Miconazole Nitrate Vaginal Suppositories USP, 100 mg
    Cures Most Vaginal Yeast Infections
    Contains 7 Vaginal Suppositories

    Drug Facts
    Active ingredient (in each vaginal suppository)                                                                         Purpose
    Miconazole nitrate 100 mg.........................................................................................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
    • 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 by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).
    • do not have vaginal intercourse

    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, 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 brochure for complete instructions
    • adults and children 12 years of age and over:
           • insert 1 suppository into the vagina at bedtime for 7 nights in a row     • wash applicator after each use
    • children under 12 years of age: ask a doctor

    Drug Facts
    (continued)
    Other information
    • store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F).
    • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)

    Inactive ingredient
    hydrogenated vegetable oil base

    Drug Facts
    (continued)
    Questions? call 1-800-922-1038

    Manufactured by: G&W Laboratories, Inc.
    111 Coolidge Street
    South Plainfield, NJ 07080
    Visit our website @ www.gwlabs.com

    Repackaged by: Rebel Distributors Corp.
    3607 Old Conejo Rd.
    Thousand Oaks, CA 91320

     


    TAMPER-EVIDENT: For your safety each suppository is individually wrapped. If a suppository is unwrapped or there are signs of tampering, DO NOT USE.
     

    Miconazole Nitrate 100mg
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  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42254-295(NDC:0713-0197)
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole Nitrate (Miconazole) Miconazole Nitrate 100 ug
    Inactive Ingredients
    Ingredient Name Strength
    Hydrogenated Coconut Oil  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42254-295-07 7 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074414 04/30/1997
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    Name Address ID/FEI Business Operations
    PSS World Medical, Inc. 791528623 REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 RELABEL(42254-295), REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    SCRIPT PAK 964420108 RELABEL(42254-295), REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distirbutors Corp. 118802834 RELABEL(42254-295), REPACK(42254-295)
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