FDA.reportPublic FDA data

Miconazole 7

Manufacturer
CVS Pharmacy | Sun Pharma Canada Inc.
Effective date
2026-09-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-15 03:02:06

Label at a glance#

ProductMiconazole 7
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Indications and uses

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

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: applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fin...

Storage and handling

do not use if seal over tube opening has been punctured do not purchase if carton is open store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate USP 2%

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For vaginal use only

OTC - DO NOT USE SECTION

Do not use 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking the prescription blood thinning medicine 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. 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
  • if you do not get complete relief ask a doctor before using another product

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • before using this product read the enclosed consumer information leaflet for complete directions and information
  • adults and children 12 years of age and over:
    • applicators:insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use.
    • use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. 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

STORAGE AND HANDLING SECTION

  • do not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.

Questions?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSHealth ™

Compare to the active ingredient in Monistat ®7 Vaginal Cream*

7-Day Treatment

Miconazole 7

MICONAZOLE NITRATE VAGINAL
CREAM USP (2%)

Vaginal antifungal

NET WT 1.5 OZ (45 g) TUBE + 7 DISPOSABLE APPLICATORS

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-988-072023-03-13C16284748780-1ba0f9c33-18e6-a910-e053-dadaa90a0b85Miconazole 7
69842-988-072023-03-13C16284748780-1ba0f9c33-18e6-a910-e053-dadaa90a0b85Miconazole 7
69842-988-072023-01-30C16284748780-1ba0f9c33-18e6-a910-e053-dadaa90a0b85Miconazole 7
69842-988-072023-01-30C16284748780-1ba0f9c33-18e6-a910-e053-dadaa90a0b85Miconazole 7
69842-988-072021-04-05C16284748780-1ba0f9c33-18e6-a910-e053-dadaa90a0b85Miconazole 7
69842-988-072021-04-05C16284748780-1ba0f9c33-18e6-a910-e053-dadaa90a0b85Miconazole 7
69842-988-072021-01-29C16284748780-1ba0f9c33-18e6-a910-e053-dadaa90a0b85Miconazole 7
69842-988-072021-01-29C16284748780-1ba0f9c33-18e6-a910-e053-dadaa90a0b85Miconazole 7

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-98869842-988-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
BENZOIC ACID8SKN0B0MIMIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-05-27full-release2026-06-01 01:01:37

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074444-001MICONAZOLE NITRATEMICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1384e616aacf4f…
2026-08-18 06:07:402026-07A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074444-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-01-13f41ea6bd6efb…

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
362a5224-f51c-e0fc-e063-6394a90ad1765e7e4cf8-24ec-486e-9389-546ffea004d02025-05-27WarningsExact identifier
spl set id: 5e7e4cf8-24ec-486e-9389-546ffea004d0

Reported adverse events (FAERS/openFDA)#

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