FDA.reportPublic FDA data

MONISTAT 3 Combination Pack - prefilled app and cream

Manufacturer
Apex International Mfg., Inc.
Effective date
2020-04-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:21:09

Label at a glance#

ProductMonistat 3 Combination Pack
Active ingredientMiconazole Nitrate
Label structure9 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 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use. external cream:  squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Us...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Purpose

OTC - PURPOSE SECTION

Miconazole nitrate 4% (200 mg in each applicator)       Vaginal antifungal

Miconazole nitrate 2% (external cream)       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

  • 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 are 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
  • 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

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:
    • applicators: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use.
    • external cream: 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

SPL UNCLASSIFIED SECTION

  • do not use if printed suppository wrapper is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Monistat®
C O M B I N A T I O N  P A C K

Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)

VAGINAL ANTIFUNGAL

• CURES most vaginal YEAST INFECTIONS
• Relieves associated external itching and irritation

3 PREFILLED APPLICATORS
plus External Cream for Itch Relief

Net Wt. 0.18 oz (5g) each applicator
+ 0.32 oz (9g) Tube

3-DAY
TREATMENT
COMBINATION PACK

Prefilled Cream

3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief

TAMPER-EVIDENT UNIT DO NOT
USE IF PRINTED APPLICATOR
WRAPPER IS TORN, OPEN OR
INCOMPLETELY SEALED.

If you have any
questions or
comments, please call
1-877-MONISTAT
(1-877-666-4782)

Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
A Prestige Consumer Healthcare company
©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
All rights reserved. MNUS013106

carton
carton

Monistat®
C O M B I N A T I O N  P A C K

Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Vaginal Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)

VAGINAL ANTIFUNGAL

• CURES most vaginal YEAST INFECTIONS
• Relieves associated external itching and irritation

3 PREFILLED APPLICATORS
plus External Cream for Itch Relief

Net Wt. 0.18 oz (5g) each applicator
+ 0.32 oz (9g) Tube

3-DAY
TREATMENT
COMBINATION PACK

Prefilled Cream

3 Ready-to-Use Prefilled Applicators plus External Cream for Itch Relief

TAMPER-EVIDENT UNIT DO NOT
USE IF PRINTED APPLICATOR
WRAPPER IS TORN, OPEN OR
INCOMPLETELY SEALED.

If you have any
questions or
comments, please call
1-877-MONISTAT
(1-877-666-4782)

Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
A Prestige Consumer Healthcare company
©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
All rights reserved. MNUS001107

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
992771{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]BPCK2
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCK2
998540miconazole nitrate 2 % Vaginal CreamPSN2
992765miconazole nitrate 200 MG Vaginal InsertPSN2
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN2
998544miconazole nitrate 4 % Vaginal CreamPSN2
998541Monistat 2 % Vaginal CreamPSN2
992770Monistat 3 200 MG Vaginal InsertPSN2
998546MONISTAT 3 4 % Vaginal CreamPSN2
992771Monistat 3 Day Ovule Combination PackPSN2
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD2
992770miconazole nitrate 200 MG Vaginal Insert [Monistat]SBD2
998546miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]SBD2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD2
992765miconazole nitrate 200 MG Vaginal InsertSCD2
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD2
992771{1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]SY2
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY2
992766miconazole 3 Day Vaginal Insert Combination PackSY2
998540miconazole nitrate 2 % Vaginal CreamSY2
998544miconazole nitrate 4 % Vaginal CreamSY2
998541Monistat 20 MG/ML Vaginal CreamSY2
992770Monistat 200 MG Vaginal InsertSY2
992771Monistat 3 Day Ovule Combination PackSY2
998546Monistat 4 % Vaginal CreamSY2
998546Monistat 40 MG/ML Vaginal CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
57501-006-012022-01-28C16284748780-1d6a99b39-425b-a426-e053-dadaa90af4c2MONISTAT 3 Combination Pack - prefilled app and cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57501-006-01Monistat 3 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57501-006MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [APEX INTERNATIONAL MFG., INC.]2Legacy NDC, 1 package rows20200714_02c497e9-3b72-4dd2-83eb-a62b2eba1a9f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57501-00657501-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
BENZOIC ACID8SKN0B0MIMIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
Miconazole NitrateVW4H1CYW1KACTIB
Benzoic Acid8SKN0B0MIMIACT
Cetyl Alcohol936JST6JCNIACT
Isopropyl Myristate0RE8K4LNJSIACT
Polysorbate 60CAL22UVI4MIACT
Potassium HydroxideWZH3C48M4TIACT
Propylene glycol6DC9Q167V3IACT
Water059QF0KO0RIACT
Stearyl Alcohol2KR89I4H1YIACT

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
N020670-002MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16

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 22:38:342026-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1684e616aacf4f…
2026-08-18 06:07:402026-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16f41ea6bd6efb…

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
bde53bec-6b4a-4fdd-9499-9306b04ce4d202c497e9-3b72-4dd2-83eb-a62b2eba1a9f2020-04-23WarningsExact identifier
spl id: bde53bec-6b4a-4fdd-9499-9306b04ce4d2
spl set id: 02c497e9-3b72-4dd2-83eb-a62b2eba1a9f

Reported adverse events (FAERS/openFDA)#

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