FDA.reportPublic FDA data

Lotrimin AF

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 00:41:09

Label at a glance#

ProductLotrimin AF 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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(To Deliver) 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

Flammable

SPL UNCLASSIFIED SECTION

Do not use while smoking or near heat or flame

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

dimethyl ether, polyoxyl 15 hydroxystearate, sd alcohol 40-B (16.5% v/v)

Questions?

OTC - QUESTIONS SECTION

1-866-360-3266

Distribution

SPL UNCLASSIFIED SECTION

Distributed by Bayer HealthCare LLC

Whippany, NJ 07981 USA

PRINCIPAL DISPLAY PANEL - 133 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Liquid Spray

cools the burn

NDC 11523-4327-01

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 133 gLabel 133 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998533miconazole nitrate 2 % Topical SprayPSN9
998533miconazole nitrate 20 MG/ML Topical SpraySCD9
998533miconazole nitrate 2 % Topical SpraySY9
998533miconazole nitrate 3 GM in 150 GM Topical SpraySY9

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-4327-12025-07-29C16284748780-13b156c62-2954-fb37-e063-e6dba90a4e07Lotrimin ® AF Antifungal Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4327-1Lotrimin AFAntifungal133 g in 1 CANSPRAY1339

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4327LOTRIMIN AF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [BAYER HEALTHCARE LLC.]9Legacy NDC, 1 package rows20241208_d6eb3b78-405b-43e5-9db5-da671465eda1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4327-1GM - Gram11523-43275746ffda-6ca7-446e-a6b8-9105d7b39c1c12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Miconazole nitrateACTIVE INGREDIENTVW4H1CYW1K1
MiconazoleACTIVE MOIETY7NNO0D7S5M1
dimethyl etherINACTIVE INGREDIENTAM13FS69BX1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-432711523-4327-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL ETHERAM13FS69BXIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

Source Document#

Source XML

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
289f2ae0-fccd-df93-e063-6394a90a270fd6eb3b78-405b-43e5-9db5-da671465eda12024-12-06WarningsExact identifier
spl id: 289f2ae0-fccd-df93-e063-6394a90a270f
spl set id: d6eb3b78-405b-43e5-9db5-da671465eda1

Reported adverse events (FAERS/openFDA)#

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