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Monistat Tioconazole 1 drug information

TIOCONAZOLE
Insight Pharmaceuticals LLC · TOPICAL

Product NDC: 63736-413

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameTIOCONAZOLE
Labeler / manufacturerInsight Pharmaceuticals LLC
RouteTOPICAL
Drug classAzole Antifungal
Product NDC63736-413
Label effective date2026-09-04

Official product label reference

Monistat Tioconazole 1 — Insight Pharmaceuticals LLC

This page contains 14 source sections for TIOCONAZOLE, topical route. Label set 587e42b4-cbdc-4a03-afae-f9e5e6605937, version 2.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses treats vaginal yeast infections

Purpose

Purpose Vaginal antifungal
Dosage and administration — label text
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.
Warnings
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).
Unclassified section
Drug Facts Other i nformation 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
Active ingredient
Active ingredient (in each applicator) Tioconazole 300 mg (6.5%)
Do not use
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Ask a doctor before use
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
While using this medicine
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
When to stop use and seek help
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 .
Pregnancy or breast feeding
If pregnant or breast- feeding ask a health professional before use
Child safety
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Inactive ingredient
Inactive ingredients butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum
Questions
Questions? 1-877-666-4782

Official sources and product identifiers

Substances listed: TIOCONAZOLE

RxNorm identifiers: 198380, 1661176

Package NDC codes

63736-413-01

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.