Miconazole Nitrate Vaginal Cream 2 % 7 Day Vaginal Cream

Manufacturer
REMEDYREPACK INC.
Effective date
2019-07-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:17:59

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Indications and uses

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

Storage and handling

• 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.

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
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 medication warfarin, because bleeding or bruising may occur.

When using this product
• 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
• 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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING 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 INGREDIENT

INACTIVE INGREDIENT SECTION

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

QUESTIONS

OTC - QUESTIONS SECTION

1-800-922-1038

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Miconazole Nitrate

GENERIC: Miconazole Nitrate

DOSAGE: CREAM

ADMINSTRATION: VAGINAL

NDC: 70518-0811-0

PACKAGING: 45 g in 1 TUBE, WITH APPLICATOR

ACTIVE INGREDIENT(S):

  • Miconazole Nitrate 20mg in 1g

INACTIVE INGREDIENT(S):

  • Benzoic Acid
  • Peg-5 Oleate
  • Pegoxol 7 Stearate
  • Butylated Hydroxyanisole
  • Mineral Oil
  • Water

Remedy_LabelRemedy_Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixDUMMY BARCODE QUERY STRING DUMMY BARCODE QUERY STRING DUMMY BARCODE QUERY STRING DUMMY BARCODE QUERY STRING DUMMY BARCODE QUERY STRINGRemedy_Label.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0252-37GM - Gram0713-02524eef55c7-51cd-4f3e-aa0f-27909ec64d7b12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-081170518-0811-0
0713-0252

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

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
A074366-001MICONAZOLE NITRATEMICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22

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 22:38:342026-08A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2284e616aacf4f…
2026-08-18 06:07:402026-07A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-223f01610625f2…
2019-09-15 20:21 UTC2019-09A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074366-001MICONAZOLE NITRATE2%CREAM / VAGINAL1996-02-22f41ea6bd6efb…

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
a4fa6d6c-1927-94e8-e053-2a95a90a66d0b7b6cabe-9078-4e90-abac-914223672ec52020-05-06WarningsExact identifier
spl set id: b7b6cabe-9078-4e90-abac-914223672ec5

Reported adverse events (FAERS/openFDA)#

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