Monistat 7 Cream
FDA Label NDC 63736-026

14 label sections · Submitted to the FDA by Insight Pharmaceuticals Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Monistat 7 (NDC 63736-026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purpose

Miconazole nitrate 2% ……………….………………………………….Vaginal antifungal

Uses

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

Warnings

For vaginal use only.

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:
    ○ applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away 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 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 seal over tube opening has been punctured 
  • 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

MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)

Vaginal Antifungal

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

Principal Display Panelmonistat® 7miconazole Nitrate Vaginal Cream (2%) Vaginal Antifungalnet Wt. 1.59 Oz. (45g) Tube + 7 Disposable Applicators (Monistat 7 Simply   7 Dispos Apps Cream 01)

Principal Display Panelmonistat® 7miconazole Nitrate Vaginal Cream (2%) Vaginal Antifungalnet Wt. 1.59 Oz. (45g) Tube + 7 Disposable Applicators (Monistat 7 Simply 7 Dispos Apps Cream 01)

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