Miconazole Nitrate Vaginal Cream

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2019-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:39:51

Label at a glance#

ProductMiconazole 7
Active ingredientMICONAZOLE NITRATE
Label structure17 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: applicator: 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 fing...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate, USP 2% (100 mg in each applicator)

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

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 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

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 directions and information
  • adults and children 12 years of age and over:
    • applicator: 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 to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.
  • children under 12 years of age:  ask a doctor

Other information

OTHER SAFETY INFORMATION

  • to open tube use cap to puncture seal
  • 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 or 86°F.)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxyl 7 stearate, purified water

Questions?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3219-72024-07-30C16284748780-1ba0f9c33-4014-a910-e053-dadaa90a0b85Miconazole Nitrate Vaginal Cream
68071-3219-72021-01-29C16284748780-1ba0f9c33-4014-a910-e053-dadaa90a0b85Miconazole Nitrate Vaginal Cream

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0730-41GM - Gram0472-0730608157e8-46b9-48c2-b35e-8d1bb87ee87612012-07-24
0472-0730-63GM - Gram0472-0730ff103514-2f56-452d-ac6c-27c42aeb5c7012012-07-24

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
68071-321968071-3219-7
0472-0730

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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
A074164-001MICONAZOLE 7MICONAZOLE NITRATE2%CREAM / VAGINAL1996-03-29

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 22:38:342026-08A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-2984e616aacf4f…
2026-08-18 06:07:402026-07A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-293f01610625f2…
2019-09-15 20:21 UTC2019-09A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29f41ea6bd6efb…

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
1cc0fb91-ad2e-0741-e063-6394a90ae72855270c7a-72d8-644d-e054-00144ff8d46c2024-07-08WarningsExact identifier
spl set id: 55270c7a-72d8-644d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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