Monistat 3 Cream
FDA Label NDC 63736-015

Full FDA labeling including 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 3 (NDC 63736-015). 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 active ingredient, purpose, use, warnings, do not use if, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole nitrate 4% (200 mg in each applicatorful)

Purpose

Vaginal antifungal

Use

  • treats vaginal yeast infections

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 after 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 and over:
    • applicators: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.

    • children under 12 years of age: ask a doctor

Other Information

  • do not use if printed applicator wrapper is torn, open or incompletely sealed
  • do not purchase if carton is open
  • store at 20° - 25°C (68° to 77°F)

Inactive Ingredients

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

Call toll-free 877-666-4782 or 215-273-8755 (collect)

Principal Display Panel - 5 G Tube Carton

3 DAY TREATMENT • CREAM

MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)
(Miconazole Nitrate 200 mg per applicator)
VAGINAL ANTIFUNGAL

Net Wt. 0.18 oz. (5g) each applicator

3 Day Treatment • Creammonistat® 3miconazole Nitrate Vaginal Cream (4%)(miconazole Nitrate 200 mg Per Applicator)vaginal Antifungalnet Wt. 0.18 Oz. (5g) Each Applicator (Monistat 3 3 Day Pre Filled 63736 015 18 01)

3 Day Treatment • Creammonistat® 3miconazole Nitrate Vaginal Cream (4%)(miconazole Nitrate 200 mg Per Applicator)vaginal Antifungalnet Wt. 0.18 Oz. (5g) Each Applicator (Monistat 3 3 Day Pre Filled 63736 015 18 01)

* Please review the disclaimer below.