Miconazole 7

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2025-02-03
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:54:16

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: applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator 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....

Storage and handling

to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use do not use if foil seal on tube opening is broken or missing do not purchase if carton is open store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F) before using any medication, read all label directions. Keep carton, it contains important information.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

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

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:
- applicator:insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator 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

STORAGE AND HANDLING SECTION

to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
do not use if foil seal on tube opening is broken or missing
do not purchase if carton is open
store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-877-753-3935Monday-Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998540	miconazole nitrate 2 % Vaginal Cream	PSN	2
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	2
998540	miconazole nitrate 2 % Vaginal Cream	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MICONAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3544-7	2025-02-03	C162847	48780-1	2cef2736-74e2-d83d-e063-dadaa90ab31f	Miconazole 7
68071-3544-7	2025-01-30	C162847	48780-1	2cef2736-74e2-d83d-e063-dadaa90ab31f	Miconazole 7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3544-7	Miconazole 7	1 in 1 CARTON	CREAM	1		2
68071-3544-7	Miconazole 7	45 g in 1 TUBE, WITH APPLICATOR	CREAM	45		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3544	MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 2 package rows	20250205_0c055a0d-1031-e7d5-e063-6294a90a17e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-730-41	GM - Gram	61269-730	c08120f8-57b4-41e7-b73b-aebd8fac5f5c	1	2021-05-05
61269-730-63	GM - Gram	61269-730	f361e5bb-302a-4a82-818f-5ac9991e1ac8	1	2021-04-08

Products#

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

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

Miconazole 7
Miconazole Nitrate
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
MINERAL OIL
APRICOT KERNEL OIL PEG-6 ESTERS
PEGOXOL 7 STEARATE
WATER
MICONAZOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-3544	68071-3544-7
61269-730

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
BENZOIC ACID	8SKN0B0MIM	IACT
BUTYLATED HYDROXYANISOLE	REK4960K2U	IACT
MINERAL OIL	T5L8T28FGP	IACT
APRICOT KERNEL OIL PEG-6 ESTERS	DRG3KJZ1TJ	IACT
PEGOXOL 7 STEARATE	3EW5AXE5X5	IACT
WATER	059QF0KO0R	IACT
MICONAZOLE NITRATE	VW4H1CYW1K	ACTIB

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074164-001	MICONAZOLE 7	MICONAZOLE NITRATE	2%	CREAM / VAGINAL			1996-03-29

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074164-001	MICONAZOLE 7	2%	CREAM / VAGINAL	1996-03-29	`f41ea6bd6efb…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 7	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	0c055a0d-1031-e7d5-e063-6294a90a17e2	2025-02-03	Warnings	Exact identifier ndc (package): 68071-3544-7 ndc (product): 68071-3544 ndc11 (package): 68071354407 spl id: 2d3fbb35-987f-7d36-e063-6394a90a1acd spl set id: 0c055a0d-1031-e7d5-e063-6294a90a17e2
Miconazole 7	MICONAZOLE NITRATE	H2-Pharma, LLC	4bf1a555-a24f-4807-ac13-db19c55cf280	2023-01-13	Warnings	Exact identifier ndc (product): 61269-730
Miconazole 7	MICONAZOLE NITRATE	H2-Pharma, LLC	67dc7d38-a663-48d5-9abf-b3bd8dc0eddf	2023-01-13	Warnings	Exact identifier ndc (product): 61269-730

Reported adverse events (FAERS/openFDA)#

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