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Monistat 1 Combination Pack: Package Insert / Prescribing Info

Package insert / product label
Generic name: miconazole nitrate
Dosage form: kit

Medically reviewed by Drugs.com. Last updated on Nov 15, 2024.

Drug Facts

Active ingredients

Purpose

Miconazole nitrate 1200 mg (in vaginal insert) Vaginal antifungal

Miconazole nitrate 2% (external cream) Vaginal antifungal

Indications and Usage for Monistat 1 Combination Pack

  • 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.

Monistat 1 Combination Pack Dosage and Administration

  • 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 applicator away.
    • 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

Kit Carton

MONISTAT®
Combination Pack

Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%) – Vaginal Antifungal
VAGINAL ANTIFUNGAL

1 OVULE® Insert Net Wt. 2.6 g +0.32oz (9g) Tube

PRINCIPAL DISPLAY PANEL
Kit Carton
MONISTAT®
Combination Pack
Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%) – Vaginal Antifungal
VAGINAL ANTIFUNGAL
1 OVULE® Insert Net Wt. 2.6 g +0.32oz (9g) Tube

MONISTAT 1 COMBINATION PACK
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-013
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-013-301 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product06/29/2001
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
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)
Mineral Oil (UNII: T5L8T28FGP)
Titanium Dioxide (UNII: 15FIX9V2JP)
Petrolatum (UNII: 4T6H12BN9U)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130806/29/2001
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
NDANDA02130806/29/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130806/29/2001
Labeler - Insight Pharmaceuticals LLC (055665422)

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