Indications and uses
treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Miconazole 3 Combination Pack
- Manufacturer
- Cardinal Health (Leader) 37205
- Effective date
- 2024-10-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 17
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:53:00
Label at a glance#
ProductMiconazole 3 Combination Pack
Active ingredientMICONAZOLE NITRATE
Label structure9 sections
Dosage and administration
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. Throw 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, irrit...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Miconazole nitrate, USP 200 mg (in each suppository)
Miconazole nitrate, USP 2% (external cream)
Purpose
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
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 3 nights in a row. Throw 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
Other information
- do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
- do not use if seal over tube opening has been punctured or is not visible
- do not purchase if carton is open
- store at room temperature 15°-30°C (59°-86°F). Avoid heat (over 30°C - 86°F)
Inactive ingredients
- suppository: hydrogenated vegetable oil
- external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
Principal Display Panel
NDC 37205-583-03
LEADER®
3 DAY TREATMENT
Disposable Applicators
VAGINAL SUPPOSITORIES plus CREAM for EXTERNAL RELIEF
Compare to
Monistat® 3
active ingredient*
Miconazole 3
Combination Pack
Miconazole Nitrate Vaginal Suppositories, USP 200 mg and
Miconazole Nitrate External Vulvar Cream, 2%
VAGINAL ANTIFUNGAL
Cures most vaginal yeast infections
Relieves associated external itching and irritation
3 Miconazole Nitrate Vaginal suppositories, USP 200 mg plus
1 tube of Miconazole Nitrate External Vulvar Cream - NET WT 0.32 oz (9 g)
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37205-583-03 | EA - Each | 37205-583 | bfd3b2c8-ed4b-4ce4-82e1-7bad1b347a51 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | 1 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | 1 |
Products#
Every source-derived product name is available through these pages.
- Miconazole 3 Combination Pack
- miconazole nitrate
- miconazole 3
- MICONAZOLE
- HYDROGENATED PALM KERNEL OIL
- BENZOIC ACID
- BUTYLATED HYDROXYANISOLE
- MINERAL OIL
- APRICOT KERNEL OIL PEG-6 ESTERS
- PEGOXOL 7 STEARATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37205-583 | 37205-583-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| HYDROGENATED PALM KERNEL OIL | FM8D1RE2VP | IACT |
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| APRICOT KERNEL OIL PEG-6 ESTERS | DRG3KJZ1TJ | IACT |
| PEGOXOL 7 STEARATE | 3EW5AXE5X5 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074926-001 | M-ZOLE 3 COMBINATION PACK | MICONAZOLE NITRATE | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074926-001 | M-ZOLE 3 COMBINATION PACK | 2%,200MG | CREAM, SUPPOSITORY / TOPICAL, VAGINAL | 1999-04-16 | 3a93d1ddd44b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9e476940-495d-4d8a-b8db-20ae8a772e52 | 79b61ece-7590-4448-86fa-28ab3d3cc074 | 2024-10-09 | Warnings | 9e476940-495d-4d8a-b8db-20ae8a772e52 79b61ece-7590-4448-86fa-28ab3d3cc074 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.