Indications and uses
treats repeat vaginal yeast infections relieves external itching and irritation due to a repeat vaginal yeast infection
treats repeat vaginal yeast infections relieves external itching and irritation due to a repeat vaginal yeast infection
before using this product read the enclosed consumer information leaflet for complete instructions adults and children 12 years of age and over: applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use daily for up to 7 days as needed childr...
Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)
Vaginal antifungal
treats repeat vaginal yeast infections
relieves external itching and irritation due to a repeat vaginal yeast infection
For vaginal use only
if you have never had a vaginal yeast infection diagnosed by a doctor
taking the prescription blood thinning medication warfarin, because bleeding or bruising may occur.
do not use tampons, douches, spermicides, or other vaginal products
do not have vaginal intercourse
condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)
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
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
before using this product read the enclosed consumer information leaflet for complete instructions
adults and children 12 years of age and over:
children under 12 years of age: ask a doctor
do not use if seal over tube opening has been punctured or cannot be seen
store at room temperature 15°-30°C (59-86°F). Avoid heat over 30°C or 86°F.
benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
1-800-200-6313
NDC 37205-590-29
LEADER®
7 DAY VAGINAL CREAM
Miconazole NitrateVAGINAL CREAM 2% • VAGINAL ANTIFUNGAL
Cures most vaginal yeast infections.
Relieves external vulvar itching and irritation associated with a yeast infection
Compare to Monistat® 7 active ingredient*
NET WT 1.59 OZ (45 g)
SATISFACTION GUARANTEED
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OH 43017
CIN 1362490
www.myleader.com
1-800-200-6313
All Leader®
Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
*This product is not manufactured or distributed by Johnson & Johnson, distributor or manufacturer of MONISTAT® 7. MONISTAT® 7 is a registered trademark of Johnson & Johnson.
10-25237LR2

| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37205-590-29 | 2025-04-16 | C162847 | 48780-1 | 9d75b9d0-d3ae-f424-e053-dadaa90a57ce | DRUG FACTS |
| 37205-590-29 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d3ae-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37205-590-29 | GM - Gram | 37205-590 | dbc8a823-513d-4c95-a59b-ac6101e27f89 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Miconazole Nitrate | ACTIVE INGREDIENT | VW4H1CYW1K | 1 | |
| Miconazole | ACTIVE MOIETY | 7NNO0D7S5M | 1 | |
| Benzoic Acid | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| Butylated Hydroxyanisole | INACTIVE INGREDIENT | REK4960K2U | 1 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| Peg-5 Oleate | INACTIVE INGREDIENT | 0240V77G50 | 1 | |
| Pegoxol 7 Stearate | INACTIVE INGREDIENT | 3EW5AXE5X5 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 37205-590 | 37205-590-29 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Miconazole Nitrate | VW4H1CYW1K | ACTIB |
| Benzoic Acid | 8SKN0B0MIM | IACT |
| Butylated Hydroxyanisole | REK4960K2U | IACT |
| Mineral Oil | T5L8T28FGP | IACT |
| Peg-5 Oleate | 0240V77G50 | IACT |
| Pegoxol 7 Stearate | 3EW5AXE5X5 | IACT |
| Water | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / RECTAL | 1 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | ELIXIR / ORAL | 90 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | CREAM / TOPICAL | 6 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | CREAM / VAGINAL | 10 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAVENOUS | 5 %w/v | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / SUBLINGUAL | 2 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | GEL / TOPICAL | 7 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| Pegoxol 7 Stearate | PEGOXOL 7 STEARATE | 3EW5AXE5X5 | CREAM / VAGINAL | 20 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / TOPICAL | 0.1 %w/w | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | CONCENTRATE / ORAL | 0.08 mg/1ml | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | SOLUTION / ORAL | 5 mg | ||
| Peg-5 Oleate | PEG-5 OLEATE | 0240V77G50 | SOLUTION / ORAL | 1600 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / TOPICAL | 0.01 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| Pegoxol 7 Stearate | PEGOXOL 7 STEARATE | 3EW5AXE5X5 | LOTION / TOPICAL | NA | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / ORAL | 100 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | FILM / SUBLINGUAL | 0.08 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / IRRIGATION | 0.02 %w/v | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | SYRUP / ORAL | 1 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SYRUP / ORAL | 20 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | LOTION / TOPICAL | NA | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | LOTION / TOPICAL | 0.2 %w/w | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / TOPICAL | 2 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | CONCENTRATE / ORAL | 12.5 mg/5ml | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| Pegoxol 7 Stearate | PEGOXOL 7 STEARATE | 3EW5AXE5X5 | SUPPOSITORY / VAGINAL | 200 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | LIQUID / ORAL | 2 mg/1ml | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE / ORAL | 4 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | INJECTION, SOLUTION / INTRAMUSCULAR | 0.2 %w/v | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / VAGINAL | 1 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / VAGINAL | 0.02 %w/w | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / RECTAL | 0.1 %w/w | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION / INTRAVENOUS | NA | ||
| Pegoxol 7 Stearate | PEGOXOL 7 STEARATE | 3EW5AXE5X5 | CREAM / TOPICAL | 640 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / VAGINAL | 0.03 %w/w |
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 |
|---|---|---|---|---|---|---|
| 022466e1-0dbe-4370-8306-88371372ad8c | 1b95ccd9-ce8d-50cb-2db1-05ad9924811a | 2025-04-11 | Warnings | 1b95ccd9-ce8d-50cb-2db1-05ad9924811a |
Adverse event summaries are temporarily unavailable. Other product information remains available.