Azolen

Manufacturer: Stratus Pharmaceuticals, Inc. | TARMAC PRODUCTS INC
Effective date: 2025-10-30
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:41:28

Label at a glance#

ProductAzolen

Active ingredientMiconazole Nitrate

Label structure12 sections

Indications and uses

Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) For effective relief of itchy, scaly skin between the toes.

Dosage and administration

Clean and dry the affected area. Cover the affected area with a thin layer twice a day (a.m. and p.m.) on skin, under nails and surrounding cuticle areas. Supervise children in the use of this product. For athlete's foot and ringworm use daily for four (4) weeks. This product is not effective on scalp or nails.

Storage and handling

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature.

Contacts and useful links#

PhoneLabel contact1-800-442-7882

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Topical Antifungal

Uses

INDICATIONS & USAGE SECTION

Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
For effective relief of itchy, scaly skin between the toes.

WARNINGS

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under supervision of doctor.

OTC - WHEN USING SECTION

Avoid contact with eyes.

OTC - STOP USE SECTION

If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean and dry the affected area.
Cover the affected area with a thin layer twice a day (a.m. and p.m.) on skin, under nails and surrounding cuticle areas.
Supervise children in the use of this product.
For athlete's foot and ringworm use daily for four (4) weeks.
This product is not effective on scalp or nails.

Other Information

STORAGE AND HANDLING SECTION

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Glacial Acetic Acid, Isopropyl Alcohol, Laureth-4, Purified Water and Sodium Hydroxide Solution.

SPL UNCLASSIFIED SECTION

For more information, see enclosed package insert.

Questions?

OTC - QUESTIONS SECTION

1-800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
STRATUS PHARMACEUTICALS INC
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58980-818-10

AZOLEN™
TINCTURE

(MICONAZOLE NITRATE USP, 2%)

TOPICAL ANTIFUNGAL

Distributed by:
STRATUS

NET VOL.: 1.0 FL OZ (29.57 mL)

Principal Display Panel - 29.57 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998525	miconazole nitrate 2 % Topical Solution	PSN	4
998525	miconazole nitrate 20 MG/ML Topical Solution	SCD	4
998525	miconazole nitrate 2 % Topical Solution	SY	4

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
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58980-818-10	Azolen	29.57 mL in 1 BOTTLE, WITH APPLICATOR	TINCTURE	29.57		4
58980-818-10	Azolen	1 in 1 BOX	TINCTURE	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58980-818-10	ML - Milliliter	58980-818	5725ebf8-1f7d-4134-bb0d-aa43535c4da2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	2
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	2
Acetic Acid	INACTIVE INGREDIENT	Q40Q9N063P	2
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	2
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	2
Laureth-4	INACTIVE INGREDIENT	6HQ855798J	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Azolen
Miconazole Nitrate
Miconazole
Water
Benzyl Alcohol
Acetic Acid
Isopropyl Alcohol
Laureth-4
Sodium Hydroxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58980-818	58980-818-10

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
Miconazole Nitrate	VW4H1CYW1K	ACTIB
Water	059QF0KO0R	IACT
Benzyl Alcohol	LKG8494WBH	IACT
Acetic Acid	Q40Q9N063P	IACT
Isopropyl Alcohol	ND2M416302	IACT
Laureth-4	6HQ855798J	IACT
Sodium Hydroxide	55X04QC32I	IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2017-10-19	full-release	2026-05-31 22:52:46

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	CREAM / TOPICAL	1.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	LOTION, AUGMENTED / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SOLUTION / TOPICAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	DISC / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SHAMPOO / TOPICAL		3 mg	Exact identifier — unii+route 36 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SHAMPOO / TOPICAL		3 mg	Exact identifier — unii+route 36 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	SOLUTION / TOPICAL	5.22 %w/v		Exact identifier — unii+route 8 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	JELLY / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	SOLUTION / TOPICAL	5.22 %w/v		Exact identifier — unii+route 8 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SOLUTION / TOPICAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	LOTION / TOPICAL	1.3 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	CREAM / TOPICAL	1.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / TOPICAL		70 mg	Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	AEROSOL, FOAM / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT, AUGMENTED / TOPICAL	0.11 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Laureth-4	LAURETH-4	6HQ855798J	GEL / TOPICAL		60 mg	Exact identifier — unii+route 8 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / TOPICAL		70 mg	Exact identifier — unii+route 36 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	AEROSOL, FOAM / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 14 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / TOPICAL		39 mg	Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 14 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii+route 6 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SWAB / TOPICAL	0.01 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 14 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azolen	MICONAZOLE NITRATE	Stratus Pharmaceuticals, Inc.	9c2574f3-3be4-405a-9c87-943dc6ef8777	2025-10-30	Warnings	Exact identifier ndc (package): 58980-818-10 ndc (product): 58980-818 ndc11 (package): 58980081810 spl id: 0892f504-c8a8-4aff-9901-223635b876c2 spl set id: 9c2574f3-3be4-405a-9c87-943dc6ef8777

Reported adverse events (FAERS/openFDA)#

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