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Monistat 7 Cream: Package Insert / Prescribing Info

Package insert / product label
Generic name: miconazole nitrate
Dosage form: vaginal cream
Drug class: Vaginal anti-infectives

Medically reviewed by Drugs.com. Last updated on Apr 23, 2024.

MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS- miconazole nitrate
Insight Pharmaceuticals

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MONISTAT® 7 Combination Pack

Drug Facts

Active ingredient

Miconazole nitrate 2%

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

Indications and Usage for Monistat 7 Cream

  • 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 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 disease (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 7 Cream 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:
    applicators: insert 1 applicatorful into the vagina at bedtime for 7 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

Other information

  • do not use if not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20° - 25°C (68° to 77°F)
  • Keep this carton for future refeence. It contains s=water,steoryl adkkctkln

Inactive ingredients

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® 7

COMBINATION PACK

Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL

Cream with 7 Disposable Applicators plus External Cream for Itch Relief

Net Wt. 1.59 oz (45 g) Tube + 0.32 oz (9 g) Tube + 7 Disposable Applicators

MONISTAT® 7 
COMBINATION PACK
Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL

Cream with 7 Disposable Applicators plus External Cream for Itch Relief	    

Net Wt. 1.59 oz (45 g) Tube + 0.32 oz (9 g) Tube + 7 Disposable Applicators

MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-023
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-023-151 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product04/26/1993
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 17 TUBE, WITH APPLICATOR 35 g
Part 21 TUBE 9 g
Part 1 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
15 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01745004/26/1993
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
NDANDA01745004/26/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01745004/26/1993
Labeler - Insight Pharmaceuticals LLC (055665422)

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