Miconazole Nitrate (Monistat 1 Combination Pack) Drug Information - Guideline Central

Monistat 1 Combination Pack (Miconazole Nitrate) kit

Insight Pharmaceuticals LLC
Insight Pharmaceuticals LLC
Monistat 1 Combination Pack
Miconazole Nitrate
Miconazole Nitrate
Miconazole Nitrate
Miconazole Nitrate
Miconazole
GELATIN
GLYCERIN
LECITHIN, SOYBEAN
MINERAL OIL
TITANIUM DIOXIDE
PETROLATUM
Miconazole Nitrate
Miconazole Nitrate
Miconazole Nitrate
Miconazole
Benzoic Acid
Cetyl Alcohol
Isopropyl Myristate
Polysorbate 60
Potassium Hydroxide
Propylene Glycol
Water
Stearyl Alcohol

Drug Facts

Active ingredients

Purpose

Miconazole nitrate 1200 mg (in each vaginal insert)       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:
    • 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.
  • Keep this carton for future reference. It contains important information.

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


Day or Night Stays in Place

MONISTAT® 1
COMBINATION PACK

Miconazole Nitrate Vaginal Insert (1200 mg) and
Miconazole Nitrate Cream (2%) – Vaginal Antifungal
1-DAY
TREATMENT

MAXIMUM STRENGTH

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

1-DAY TREATMENT Day or Night Stays in Place MONISTAT® 1 COMBINATION PACK Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%) – Vaginal Antifungal 1-DAY TREATMENT MAXIMUM STRENGTH 1 OVULE® Insert Net Wt. 2.6 g +0.32oz (9g) Tube

1-DAY TREATMENT Day or Night Stays in Place MONISTAT® 1 COMBINATION PACK Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%) – Vaginal Antifungal 1-DAY TREATMENT MAXIMUM STRENGTH 1 OVULE® Insert Net Wt. 2.6 g +0.32oz (9g) Tube
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