On this page
Miconazole 3 Combination Pack
Miconazole Nitrate · Kit
Overview
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 074926-001 | M-ZOLE 3 COMBINATION PACK | CREAM, SUPPOSITORY | MICONAZOLE NITRATE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 18 | Labeling | Approved | June 19, 2018 | Standard |
| Supplement | 8 | Labeling | Approved | April 8, 2005 | — |
| Supplement | 6 | Labeling | Approved | August 14, 2003 | — |
| Supplement | 4 | Labeling | Approved | November 21, 2002 | — |
| Supplement | 3 | Manufacturing (CMC) | Approved | March 15, 2002 | — |
| Supplement | 2 | Manufacturing (CMC) | Approved | December 4, 2001 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | December 29, 2000 | — |
| Original application | 1 | Approved | April 16, 1999 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250908). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Purpose
openFDA Drug LabelingPurpose Vaginal antifungal Vaginal antifungal
Dosage and Administration
openFDA Drug LabelingDirections 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 3 nights in a row. Wash applicator away after use. external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently 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
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 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 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.
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 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
Active Ingredient
openFDA Drug LabelingActive ingredients Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 59779-773-43 | 59779-773 | CVS Pharmacy | 1 KIT in 1 PACKAGE, COMBINATION (59779-773-43) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE | March 1, 2001 |
| 68016-731-04 | 68016-731 | Chain Drug Consortium, LLC | 1 KIT in 1 PACKAGE, COMBINATION (68016-731-04) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE | September 11, 2003 |
| 49035-345-03 | 49035-345 | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 1 KIT in 1 PACKAGE, COMBINATION (49035-345-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE | May 1, 2020 |
| 59779-773 | 59779-773 | CVS Pharmacy | — | March 1, 2001 |
| 68016-731 | 68016-731 | Chain Drug Consortium, LLC | — | September 11, 2003 |
| 49035-345 | 49035-345 | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | — | May 1, 2020 |
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 |
Generated September 25, 2026 · 7 sections on this page.