Label: MONISTAT 3 COMBINATION PACK- miconazole nitrate kit

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

Drug Label Information

Updated April 23, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredients

  • Purpose

    Miconazole nitrate 4% (200 mg in each applicator)       Vaginal antifungal

    Miconazole nitrate 2% (external cream)       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 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use.
      • external cream: 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 printed suppository wrapper is torn, open or incompletely sealed
    • 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®
    C O M B I N A T I O N  P A C K
    Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)
    (Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)

    VAGINAL ANTIFUNGAL

    • CURES most vaginal YEAST INFECTIONS
    • Relieves associated external itching and irritation

    3 PREFILLED APPLICATORS
    plus External Cream for Itch Relief

    Net Wt. 0.18 oz (5g) each applicator
    + 0.32 oz (9g) Tube

    3-DAY
    TREATMENT
    COMBINATION PACK

    Prefilled Cream

    3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief

    TAMPER-EVIDENT UNIT DO NOT
    USE IF PRINTED APPLICATOR
    WRAPPER IS TORN, OPEN OR
    INCOMPLETELY SEALED.

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

    Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
    A Prestige Consumer Healthcare company
    ©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
    All rights reserved. MNUS013106

    carton

    Monistat®
    C O M B I N A T I O N  P A C K
    Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)
    (Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)

    VAGINAL ANTIFUNGAL

    • CURES most vaginal YEAST INFECTIONS
    • Relieves associated external itching and irritation

    3 PREFILLED APPLICATORS
    plus External Cream for Itch Relief

    Net Wt. 0.18 oz (5g) each applicator
    + 0.32 oz (9g) Tube

    3-DAY
    TREATMENT
    COMBINATION PACK

    Prefilled Cream

    3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief

    TAMPER-EVIDENT UNIT DO NOT
    USE IF PRINTED APPLICATOR
    WRAPPER IS TORN, OPEN OR
    INCOMPLETELY SEALED.

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

    Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
    A Prestige Consumer Healthcare company
    ©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
    All rights reserved. MNUS001107

  • INGREDIENTS AND APPEARANCE
    MONISTAT 3 COMBINATION PACK 
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57501-006
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57501-006-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product06/11/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 APPLICATOR 3 g
    Part 21 TUBE 9 g
    Part 1 of 2
    MONISTAT 3 
    miconazole nitrate cream
    Product Information
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE40 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)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067006/11/2020
    Part 2 of 2
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate10 mg  in 0.5 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
    19 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067006/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067006/11/2020
    Labeler - Apex International Mfg., Inc. (015226132)
    Registrant - Apex International Mfg., Inc. (079110793)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International Mfg., Inc.079110793manufacture(57501-006)
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