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Home > Drugs > Drugs > Monistat 3 > Monistat 3 Prescribing Information
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https://themeditary.com/pro/monistat-3-prescribing-information-13837.html

Monistat 3 Prescribing Information

Drug Detail:Monistat 3 (Miconazole vaginal [ my-caw-nah-zole ])

Drug Class:

Contents
Uses Warnings Before Taking Dosage Side effects Interactions FAQ

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

DRUG FACTS

Active ingredientsPurpose
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 3 nights in a row. Throw away applicator 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

Storage and Handling

  • do not use if printed suppository blister is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured or embossed design embossed design is not visible

  • 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
Visit our website @ www.monistat.com

PRINCIPAL DISPLAY PANEL

30014-018-03

MONISTAT® 3
COMBINATION PACK

Miconazole Nitrate Vaginal uppositories (200mg) and Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)

CURES MOST VAGINAL YEAST INFECTIONS

AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

3 Vaginal Suppositories with Reusable
Applicator
plus External Cream

Net Wt. 3 Suppositories
0.32 oz (9g) tube

Principal Display Panel
MONISTAT 3 COMBINATION PACK
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30014-018
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30014-018-031 in 1 PACKAGE, COMBINATION
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067012/10/2009
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067012/10/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067012/10/2009
Labeler - McNeil-PPC, Inc. (801375143)
Establishment
NameAddressID/FEIBusiness Operations
Draxis Specialty Pharmaceuticals Inc., Canada243604761Analysis, Manufacture

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