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Home > Drugs > Vaginal anti-infectives > Monistat 7 > Monistat 7 Cream Prescribing Information
Vaginal anti-infectives
https://themeditary.com/pro/monistat-7-cream-prescribing-information-13838.html

Monistat 7 Cream Prescribing Information

Drug Detail:Monistat 7 (Miconazole vaginal [ my-caw-nah-zole ])

Drug Class: Vaginal anti-infectives

Contents
Uses Warnings Before Taking Dosage Side effects Interactions FAQ

Drug Facts

Active ingredient

Miconazole nitrate 2% (100 mg in each applicatorful)

Purpose

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 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 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:
  • applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use.
  • use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritate skin outside the vagina (vulva). 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 seal over tube opening has been punctured or embossed design Figure not visible

  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F)

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 - 45g Tube Carton

NDC 30014-024-15

MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 100 mg per application)

CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

7 Day Vaginal Cream
with Disposable Applicators

Net Wt.
1.59 oz. (45g) tube

PRINCIPAL DISPLAY PANEL - 45g Tube Carton
MONISTAT 7 7-DAY DISPOSABLE APPLICATORS
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30014-024
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30014-024-157 in 1 CARTON
145 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01745004/15/2010
Labeler - McNeil-PPC, Inc. (801375143)

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