7 DAY VAGINAL

Manufacturer
Cardinal Health | G & W Laboratories, Inc.
Effective date
2011-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:49:31

Label at a glance#

Product7 DAY VAGINAL
Active ingredientMiconazole Nitrate
Label structure16 sections

Indications and uses

treats repeat vaginal yeast infections relieves external itching and irritation due to a repeat vaginal yeast infection

Dosage and administration

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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

  • treats repeat vaginal yeast infections

  • relieves external itching and irritation due to a repeat vaginal yeast infection

Warnings

WARNINGS SECTION

For vaginal use only

Do not use

OTC - DO NOT USE SECTION

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the prescription blood thinning medication warfarin, because bleeding or bruising may occur.

When using this product

OTC - WHEN USING SECTION

  • 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)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • children under 12 years of age: ask a doctor

Other information

INFORMATION FOR PATIENTS SECTION

  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions?

OTC - QUESTIONS SECTION

1-800-200-6313

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Label
Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-590-292025-04-16C16284748780-19d75b9d0-d3ae-f424-e053-dadaa90a57ceDRUG FACTS
37205-590-292020-01-31C16284748780-19d75b9d0-d3ae-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-590-29GM - Gram37205-590dbc8a823-513d-4c95-a59b-ac6101e27f8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1K1
MiconazoleACTIVE MOIETY7NNO0D7S5M1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIM1
Butylated HydroxyanisoleINACTIVE INGREDIENTREK4960K2U1
Mineral OilINACTIVE INGREDIENTT5L8T28FGP1
Peg-5 OleateINACTIVE INGREDIENT0240V77G501
Pegoxol 7 StearateINACTIVE INGREDIENT3EW5AXE5X51
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-59037205-590-29

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 2 · 86 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2USUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMELIXIR / ORAL90 mgExact identifier — unii candidate
23 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii candidate
23 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMCREAM / VAGINAL10 mgExact identifier — unii candidate
23 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMINJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UTABLET / SUBLINGUAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
23 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UGEL / TOPICAL7 mgExact identifier — unii candidate
24 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSUPPOSITORY / VAGINAL2 mgExact identifier — unii candidate
23 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
Pegoxol 7 StearatePEGOXOL 7 STEARATE3EW5AXE5X5CREAM / VAGINAL20 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
24 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UCONCENTRATE / ORAL0.08 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2USOLUTION / ORAL5 mgExact identifier — unii candidate
24 equally ranked IID candidates
Peg-5 OleatePEG-5 OLEATE0240V77G50SOLUTION / ORAL1600 mgExact identifier — unii candidate
5 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / TOPICAL0.01 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
Pegoxol 7 StearatePEGOXOL 7 STEARATE3EW5AXE5X5LOTION / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / ORAL100 mgExact identifier — unii candidate
23 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UFILM / SUBLINGUAL0.08 mgExact identifier — unii candidate
24 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / IRRIGATION0.02 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2USYRUP / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii candidate
23 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2ULOTION / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMCONCENTRATE / ORAL12.5 mg/5mlExact identifier — unii candidate
23 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
Pegoxol 7 StearatePEGOXOL 7 STEARATE3EW5AXE5X5SUPPOSITORY / VAGINAL200 mgExact identifier — unii candidate
4 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii candidate
23 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UCAPSULE / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMINJECTION, SOLUTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2USUPPOSITORY / VAGINAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / VAGINAL0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UINJECTION / INTRAVENOUSNAExact identifier — unii candidate
24 equally ranked IID candidates
Pegoxol 7 StearatePEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii candidate
4 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
Butylated HydroxyanisoleBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / VAGINAL0.03 %w/wExact identifier — unii candidate
24 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
022466e1-0dbe-4370-8306-88371372ad8c1b95ccd9-ce8d-50cb-2db1-05ad9924811a2025-04-11WarningsExact identifier
spl set id: 1b95ccd9-ce8d-50cb-2db1-05ad9924811a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.