FDA.reportPublic FDA data

Lotrimin

Manufacturer
Bayer HealthCare LLC.
Effective date
2026-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:28

Label at a glance#

ProductLotrimin AF Jock Itch
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

Cures most jock itch (tinea cruris) relieves Itching, burning, scaling, discomfort, and chafing associated with jock itch

Dosage and administration

wash affected area and dry thoroughly sprinkle a thin layer over affected area twice daily (morning and night) supervise children in the use of this product use daily for 2 weeks if condition persists longer, ask a doctor this product is not effective on the scalp or nails

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

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Cures most jock itch (tinea cruris)
  • relieves Itching, burning, scaling, discomfort, and chafing associated with jock itch

Warnings

WARNINGS SECTION

For external use only

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

When using this product

SPL UNCLASSIFIED SECTION

avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation occurs
  • if there is no improvement within 2 weeks

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
  • sprinkle a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • 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

benzethonium chloride, corn starch, kaolin, sodium bicarbonate, zinc oxide

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOTRIMIN ® AF


miconazole nitrate ANTIFUNGAL

MEDICATED POWDER

JOCK ITCH

CLINICALLY PROVEN

to cure most

jock itch

RELIEVES

  • Itching
  • Burning
  • Scaling
  • Chafing

NET WT 177g (6.25 OZ)

lotrimin af jock itchlotrimin af jock itch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN2
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD2
998461miconazole nitrate 2 % Topical PowderSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041100600462GTIN-13: 0041100600462
EAN-13: 0041100600462
GTIN-12: 041100600462
UPC-A: 041100600462
GTIN storage (14 digits): 00041100600462		Lotrimin AF Jock Itch 177g.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-0150-12026-01-16C16284748780-13b156c62-2d29-fb37-e063-e6dba90a4e07Lotrimin ® AF Jock Itch Powder
11523-0150-12025-07-29C16284748780-13b156c62-2d29-fb37-e063-e6dba90a4e07Lotrimin ® AF Jock Itch Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0150-1LotriminAF Jock Itch177 g in 1 CANPOWDER1772

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-015011523-0150-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744IACT
STARCH, CORNO8232NY3SJIACT
KAOLIN24H4NWX5COIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ZINC OXIDESOI2LOH54ZIACT
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
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer HealthCare LLC.1300d84f-d7ff-ec57-e063-6294a90ae0de2026-01-16WarningsExact identifier
ndc (package): 11523-0150-1
ndc (product): 11523-0150
ndc11 (package): 11523015001
spl id: 48850e7a-a19c-ce92-e063-6394a90afaaf
spl set id: 1300d84f-d7ff-ec57-e063-6294a90ae0de

Reported adverse events (FAERS/openFDA)#

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