Label: CVS MICONAZOLE 1 COMBINATION PACK- miconazole nitrate kit

  • NDC Code(s): 51316-093-01, 51316-094-01, 51316-095-01
  • Packager: CVS PHARMACY, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 24, 2026

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Miconazole nitrate 1200 mg (in 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 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 the applicator, place the vaginal insert into the vagina. Throw away applicator.
      ▪ 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 pouch 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)
    • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.
  • Inactive ingredients

    vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum

    external cream: 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

    1-Day Treatment

    Miconazole 1
    Miconazole Nitrate Vaginal Insert 1200 mg 

    & Miconazole Nitrate Vaginal Cream 2%

    Combination Pack

    Daytime or Nighttime

    Vaginal antifungal, Yeast infection relief

    Net WT 0.32oz (9g) tube

    1 Vaginal Softgel Insert + Applicator

    1-Day Treatment Miconazole 1 Miconazole Nitrate Vaginal Insert 1200 mg & Miconazole Nitrate Vaginal Cream 2% Combination Pack Daytime or Nighttime Vaginal antifungal, Yeast infection relief Net WT 0.32oz (9g) tube 1 Vaginal Softgel Insert + Applicator

  • INGREDIENTS AND APPEARANCE
    CVS MICONAZOLE 1 COMBINATION PACK 
    miconazole nitrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-093
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-093-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product01/30/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 POUCH 1 
    Part 21 TUBE 9 g
    Part 1 of 2
    MICONAZOLE NITRATE 
    miconazole nitrate suppository
    Product Information
    Item Code (Source)NDC:51316-094
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-094-011 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02130801/30/2022
    Part 2 of 2
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Item Code (Source)NDC:51316-095
    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
    1NDC:51316-095-019 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02130801/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02130801/30/2022
    Labeler - CVS PHARMACY, INC (062312574)
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