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Monistat 3 Prescribing Information

Package insert / product label
Generic name: miconazole nitrate
Dosage form: vaginal cream, vaginal suppositories

Medically reviewed by Drugs.com. Last updated on Mar 26, 2024.

Drug Facts

Active ingredients

Purpose

Miconazole nitrate (200 mg in each suppository)……………….…………...Vaginal antifungal

Miconazole nitrate 2% (external cream)……………………………………….Vaginal antifungal

Indications and Usage for Monistat 3

  • 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 3 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:
    suppositories: insert 1 suppository 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 suppository blisters 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

suppository: hydrogenated vegetable oil base

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

MONISTAT® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%)

VAGINAL ANTIFUNGAL

3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube

PRINCIPAL DISPLAY PANEL

MONISTAT® 3 
COMBINATION PACK
Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) 
VAGINAL ANTIFUNGAL
3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube

PRINCIPAL DISPLAY PANEL

MONISTAT® 3 
COMBINATION PACK
Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) 
VAGINAL ANTIFUNGAL
3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube

MONISTAT 3
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-017
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-017-031 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product04/16/1996
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 3
Part 21 TUBE 9 g
Part 1 of 2
MONISTAT 3
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
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
Product Characteristics
Colorwhite (off-white to white) Score
ShapeBULLETSize
FlavorImprint Code
Contains
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
NDANDA02067004/16/1996
Part 2 of 2
MONISTAT 3
miconazole nitrate cream
Product Information
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)
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
NDANDA02067004/16/1996
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/16/1996
Labeler - Insight Pharmaceuticals LLC (055665422)

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