Lotrimin

Manufacturer: Bayer Healthcare LLC.
Effective date: 2024-12-06
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:40:50

Label at a glance#

ProductLotrimin Antifungal

Active ingredientMICONAZOLE NITRATE

Label structure11 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) for effective relief of itching, cracking, burning, scaling and discomfort

Dosage and administration

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 week...

Storage and handling

store between 20° to 25°C (68° to 77°F)

Contacts and useful links#

PhoneLabel contact1-866-360-3266

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Flammable: Do not use while smoking or near heat or flame

SPL UNCLASSIFIED SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes
use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs
there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

wash affected area and dry thoroughly
shake can well and spray a thin layer over affected area twice daily (morning and night)
supervise children in the use of this product
for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails
in case of clogging, clean nozzle with a pin

Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

isobutane, SD alcohol 40-B (8% v/v), stearalkonium hectorite, talc

Questions?

OTC - QUESTIONS SECTION

1-866-360-3266

Distribution

SPL UNCLASSIFIED SECTION

Distributed by: Bayer HealthCare LLC, Whippany NJ

PRINCIPAL DISPLAY PANEL - 133 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Powder Spray

goes on dry

NDC 11523-0544-2

LOTRIMIN^® AF

ANTIFUNGAL

miconazole nitrate

Clinically Proven To Cure

Most Athlete's Foot

Relieves Itching,

Burning, Cracking

& Scaling

NET WT 133g (4.6 OZ)

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998428	miconazole nitrate 2 % Powder Spray	PSN	9
998428	miconazole nitrate 0.02 MG/MG Powder Spray	SCD	9
998428	miconazole nitrate 2 % Powder Spray	SY	9

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
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
11523-0544-2	2025-07-29	C162847	48780-1	3b156c62-283d-fb37-e063-e6dba90a4e07	Lotrimin ® Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11523-0544-2	LotriminAntifungal	133 g in 1 CAN	AEROSOL, POWDER	133		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-0544	LOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.]	9	Legacy NDC, 1 package rows	20241208_3650ee3d-b285-46b9-a80b-e868f22053aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-0544-2	GM - Gram	11523-0544	a4af5297-a62e-497d-9029-aaa444585c7e	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Miconazole nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	1
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	1
isobutane	INACTIVE INGREDIENT	BXR49TP611	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Lotrimin Antifungal
Miconazole nitrate
ISOBUTANE
TALC
MICONAZOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-0544	11523-0544-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ISOBUTANE	BXR49TP611	IACT
TALC	7SEV7J4R1U	IACT
MICONAZOLE NITRATE	VW4H1CYW1K	ACTIB

Source Document#

Source XML

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 1 · 39 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
talc	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
isobutane	ISOBUTANE	BXR49TP611	AEROSOL, FOAM / TOPICAL	18 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
isobutane	ISOBUTANE	BXR49TP611	AEROSOL, FOAM / RECTAL		142 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
isobutane	ISOBUTANE	BXR49TP611	AEROSOL / TOPICAL		4484 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
isobutane	ISOBUTANE	BXR49TP611	AEROSOL, SPRAY / TOPICAL		4484 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 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
289dd4d1-bed5-42a7-e063-6394a90ace68			3650ee3d-b285-46b9-a80b-e868f22053aa	2024-12-06	Warnings	Exact identifier spl id: 289dd4d1-bed5-42a7-e063-6394a90ace68 spl set id: 3650ee3d-b285-46b9-a80b-e868f22053aa

Reported adverse events (FAERS/openFDA)#

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