Label: MICONAZOLE 3 COMBINATION PACK- miconazole nitrate kit

  • NDC Code(s): 59726-989-03
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 20, 2023

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  • Drug Facts

  • Active ingredients

    Miconazole nitrate, USP 200 mg (in each suppository)
    Miconazole nitrate, USP 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

    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:
      • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Wash applicator away after use.
      • external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently 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 suppository wrapper is missing or damaged (each suppository is individually wrapped)
    • do not use if seal over tube opening has been punctured or is not visible
    • do not purchase if carton is open
    • store at 20º - 25ºC (68º - 77ºF) [see USP controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
  • Inactive ingredients

    • suppository: hydrogenated vegetable oil
    • external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
  • Questions?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Monistat® 3*

    miconazole nitrate

    Miconazole nitrate vaginal antifungal cream, USP 2%

    and Miconazole nitrate vaginal suppositories, USP 200 mg

    vaginal antifungal

    combination pack

    3 day treatment

    • Cures most vaginal yeast infections
    • Relieves associated external itching and irritation

    net wt. oz (g) tube

    + 3 suppositories with 3 disposable applicators

    *This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® 3.

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

  • Package Label

    Miconazole nitrate, USP 200 mg (in each suppository Miconazole nitrate, USP 2% (external cream)

    READYinCASE Miconazole Nitrate Combination

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 3 COMBINATION PACK 
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-989
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-989-031 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product06/25/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 9 g
    Part 21 BLISTER PACK 3 
    Part 1 of 2
    MICONAZOLE 7 
    miconazole nitrate cream
    Product Information
    Item Code (Source)NDC:59726-988
    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)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    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
    ANDAANDA07416405/01/2020
    Part 2 of 2
    MICONAZOLE 3 
    miconazole nitrate suppository
    Product Information
    Item Code (Source)NDC:59726-987
    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
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07492606/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07492606/25/2021
    Labeler - P & L Development, LLC (800014821)
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