Monistat 3 Kit
FDA Label NDC 63736-017

16 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 3 (NDC 63736-017). 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 ingredients, purpose, uses, warnings, do not use, 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 Ingredients

Miconazole nitrate (200 mg in each suppository)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

Uses

  • 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.

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:
    ○suppositories:insert 1 suppository into the vagina at bedtime for three nights in a row. Throw applicator away 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 printedsuppository blisters are torn, open or incompletely sealed
  • 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)
  • Keep this carton for future reference. It contains important information.

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, pleasecall 1-877-666-4782. 

* Please review the disclaimer below.