On this page
tioconazole 1
Tioconazole · Ointment
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Tioconazole | 6.5 g/100g | 198380 | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Azole Antifungal [EPC] | EPC | All 44 members |
| Azoles [CS] | CS | All 44 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 075915-001 | TIOCONAZOLE | OINTMENT | TIOCONAZOLE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 25 | Labeling | Approved | November 17, 2015 | Standard |
| Supplement | 15 | Labeling | Approved | April 30, 2007 | — |
| Supplement | 6 | Labeling | Approved | October 10, 2003 | — |
| Supplement | 2 | Manufacturing (CMC) | Approved | December 9, 2002 | — |
| Original application | 1 | Approved | November 21, 2001 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260404). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse • treats vaginal yeast infections
Purpose
openFDA Drug LabelingPurpose Vaginal antifungal
Dosage and Administration
openFDA Drug LabelingDirections • before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information • adults and children 12 years of age and over: • open the printed packet just before use and remove purple cap • insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. • children under 12 years of age: ask a doctor
Warnings
openFDA Drug LabelingWarnings 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 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 (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo not use if you have never had a vaginal yeast infection diagnosed by a doctor
Ask a Doctor
openFDA Drug LabelingAsk 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
Stop Use
openFDA Drug LabelingStop 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
Active Ingredient
openFDA Drug LabelingActive ingredient (in each applicator) Tioconazole 300 mg (6.5%)
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: TIOCONAZOLE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 72288-222-54 | 72288-222 | Amazon.com Services LLC | 1 POUCH in 1 CARTON (72288-222-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR | June 18, 2026 |
| 59779-718-26 | 59779-718 | CVS Pharmacy | 1 POUCH in 1 CARTON (59779-718-26) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR | November 12, 2015 |
| 37808-426-54 | 37808-426 | H E B | 1 POUCH in 1 CARTON (37808-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR | May 9, 2016 |
| 41250-426-54 | 41250-426 | Meijer Distribution Inc | 1 POUCH in 1 CARTON (41250-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR | January 9, 2008 |
| 21130-781-54 | 21130-781 | Safeway | 1 POUCH in 1 CARTON (21130-781-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR | May 1, 2026 |
| 0363-0426-54 | 0363-0426 | Walgreen Company | 1 POUCH in 1 CARTON (0363-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR | December 19, 2007 |
| 72288-222 | 72288-222 | Amazon.com Services LLC | — | June 18, 2026 |
| 59779-718 | 59779-718 | CVS Pharmacy | — | November 12, 2015 |
| 37808-426 | 37808-426 | H E B | — | May 9, 2016 |
| 41250-426 | 41250-426 | Meijer Distribution Inc | — | January 9, 2008 |
| 21130-781 | 21130-781 | Safeway | — | May 1, 2026 |
| 0363-0426 | 0363-0426 | Walgreen Company | — | December 19, 2007 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.