Label: MICONAZOLE 3 WALGREEN COMPANY- miconazole nitrate kit

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

Drug Label Information

Updated November 8, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Miconazole nitrate (200 mg in each vaginal insert)

    Miconazole nitrate 2% (external cream)

  • Purpose

    Vaginal antifungal

    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 (1-800-222-1222) 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:
      • vaginal insert: with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away 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 sealed pouches containing vaginal inserts are 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

    vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

    external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.

  • Questions?

    call toll-free 1-855-590-5695

  • PRINCIPAL DISPLAY PANEL

    - Kit Carton

    Miconazole 3

    Miconazole Nitrate Vaginal Inserts (200 mg)

    Miconazole Nitrate Cream (2%) 

    Vaginal Antifungal | 3-Day Treatment

    Net Wt. 0.32 oz (9 g) Tube & 3 Ovule Inserts

    PRINCIPAL DISPLAY PANEL
- Kit Carton

Miconazole 3
Miconazole Nitrate Vaginal Inserts (200 mg) 
Miconazole Nitrate Cream (2%) 

Vaginal Antifungal | 3-Day Treatment


Net Wt. 0.32 oz (9 g) Tube & 3 Ovule Inserts

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 3  WALGREEN COMPANY
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5203
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5203-011 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package04/18/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 APPLICATOR
    Part 21 TUBE 9 g
    Part 1 of 2
    MICONAZOLE NITRATE 
    miconazole nitrate suppository
    Product Information
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 PACKAGE
    11 in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067004/18/2016
    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 NITRATE20 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)  
    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
    NDANDA02067004/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02067004/18/2016
    Labeler - WALGREEN COMPANY (008965063)
    Registrant - Insight Pharmaceuticals (055665422)