FDA.reportPublic FDA data

Lotrimin ® AF Jock Itch Powder Spray Talc Free

Manufacturer
Bayer Healthcare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:38

Label at a glance#

ProductLotrimin AF Jock Itch
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

proven clinically effective in the treatment of most jock itch (tinea cruris) for effective relief of itching, burning, scaling and discomfort, and chafing associated with jock itch

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 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

  • proven clinically effective in the treatment of most jock itch (tinea cruris)
  • for effective relief of itching, burning, scaling and discomfort, and chafing associated with jock itch

Warnings

WARNINGS SECTION

For external use only

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

OTC - DO NOT USE SECTION

For external use only

Flammable: DO not use near heat, flame, or while smoking

Do not use on children under 2 years of age unless directed by 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 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
  • shake can well and spray 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

hydroxypropyl cellulose, isobutane, kaolin, magnseium stearate, SD alcohol 40-B (8% v/v), stearalkonium hectorite, zea mays (corn) starch

Questions?

OTC - QUESTIONS SECTION

1-866-360-3266

PRINCIPAL DISPLAY PANEL - 133 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Powder Spray

goes on dry

NDC 11523-4140-2

LOTRIMIN® AF

ANTIFUNGAL

miconazole nitrate

Clinically Proven To Cure

Most Jock Itch

Relieves Itching,

Burning, Scaling

& Chafing

NET WT 133g (4.6 OZ)

Lotrimin JI Powder Spray 133G Talc FreeLotrimin JI Powder Spray 133G Talc Free

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998428miconazole nitrate 2 % Powder SprayPSN2
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD2
998428miconazole nitrate 2 % Powder SpraySY2

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
Data codeData MatrixC00012338LOTRIMIN JI Powder Spray 133G Talc Free.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0133-1LotriminAF Jock Itch133 g in 1 CANAEROSOL, POWDER1332

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
11523-013311523-0133-1

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
STEARALKONIUM HECTORITEOLX698AH5PIACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
KAOLIN24H4NWX5COIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
ISOBUTANEBXR49TP611IACT

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.0c53cf0f-767e-a422-e063-6394a90ab7642025-12-04WarningsExact identifier
ndc (package): 11523-0133-1
ndc (product): 11523-0133
ndc11 (package): 11523013301
spl id: 4526d12f-4d38-c729-e063-6294a90a50d6
spl set id: 0c53cf0f-767e-a422-e063-6394a90ab764

Reported adverse events (FAERS/openFDA)#

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