Monistat Tioconazole 1 Ointment
FDA Label NDC 63736-413

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 Tioconazole 1 (NDC 63736-413). 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 (in each applicator), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Uses

  • 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 the human immunodeficiency virus (HIV) that causes AIDS

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 (1-800-222-1222).

Directions

  • before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
  • adults and children 12 years of age and over:
    ○ open the foil packet just before use and remove purple cap
    ○ insert entire content of applicator into the vagina at bedtime. Throw applicator away after use.
  • children under 12 years of age: ask a doctor.

Other Information

  • this product is a 1-dose treatment.  Most women do not get complete relief of their symptoms in just one day. Most women get some improvement in one day and complete relief of symptoms within 7 days.
  • if you have questions about vaginal yeast infections, consult your doctor
  • store at 20°-25°C (68°-77°F)
  • see end flap of carton for lot number and expiration date

Inactive Ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions?

1-877-666-4782

Principal Display Panel

MONISTAT®

Tioconazole Ointment 6.5%

VAGINAL ANTIFUNGAL

Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR

Principal Display Panelmonistat®tioconazole Ointment 6.5%vaginal Antifungalnet Wt. 0.16 Oz (4.6 G) Prefilled Applicator (Monistat Tioconazole Ointment 01)

Principal Display Panelmonistat®tioconazole Ointment 6.5%vaginal Antifungalnet Wt. 0.16 Oz (4.6 G) Prefilled Applicator (Monistat Tioconazole Ointment 01)

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