FDA.reportPublic FDA data

Lotrimin Daily Prevention

Manufacturer
Bayer HealthCare LLC.
Effective date
2026-01-16
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:33:32

Label at a glance#

ProductLotrimin Daily Prevention
Active ingredientTOLNAFTATE
Label structure10 sections

Dosage and administration

Directions • to prevent athlete's foot, wash the feet and dry thoroughly. • apply a thin layer of the product on the feet once or twice daily (morning and/or night). • supervise children in the use of this product. • pay special attention to spaces between the toes; wear well-fitting ventilated shoes and socks at least once daily.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Tolnaftate 1%

OTC - PURPOSE SECTION

Purpose

Antifungal

Use

INDICATIONS & USAGE SECTION

Use

• clinically proven to prevent most athlete' s foot with daily use

WARNINGS SECTION

Warnings

For external use only

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs

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

Directions

• to prevent athlete's foot, wash the feet and dry thoroughly.

• apply a thin layer of the product on the feet once or twice daily (morning and/or night).

• supervise children in the use of this product.

• pay special attention to spaces between the toes; wear well-fitting ventilated shoes and socks at least

once daily.

Other information

OTHER SAFETY INFORMATION

Other information

store between 20º to 25ºC (68º– 77ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzethonium chloride;corn starch, kaolin;sodium bicarbonate

Questions

OTC - QUESTIONS SECTION

Questions? 1-866-360-3266

Package Display 3 oz. label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOTRIMIN® AF

TOLNAFTATE ANTIFUNGAL

medicated foot powder

DAILY

PREVENTION

clinically proven to

prevent most

athlete's foot

  • stops the growth of most athlete's foot fungus
  • absorbs sweat & keeps feet dry
  • destroys odor

NET WT 90g (3 OZ)

Lotrimin Daily Prev Powder 0011 FrontLotrimin Daily Prev Powder 0011 Front

Lotrimin Daily Prev Powder 0011 BackLotrimin Daily Prev Powder 0011 Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313422tolnaftate 1 % Topical PowderPSN7
313422tolnaftate 0.01 MG/MG Topical PowderSCD7
313422tolnaftate 1 % Topical PowderSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041100587299GTIN-13: 0041100587299
EAN-13: 0041100587299
GTIN-12: 041100587299
UPC-A: 041100587299
GTIN storage (14 digits): 00041100587299		Lotrimin Daily Prev Powder_0011-2.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-0011-12026-01-16C16284748780-13b156c62-2912-fb37-e063-e6dba90a4e07Lotrimin Daily Prevention Powder UI 1612510
11523-0011-22026-01-16C16284748780-13b156c62-2912-fb37-e063-e6dba90a4e07Lotrimin Daily Prevention Powder UI 1612510
11523-0011-12025-07-29C16284748780-13b156c62-2912-fb37-e063-e6dba90a4e07Lotrimin Daily Prevention Powder UI 1612510
11523-0011-22025-07-29C16284748780-13b156c62-2912-fb37-e063-e6dba90a4e07Lotrimin Daily Prevention Powder UI 1612510

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0011-1Lotrimin Daily Prevention90 g in 1 BOTTLEPOWDER907
11523-0011-2Lotrimin Daily Prevention28 g in 1 BOTTLEPOWDER287

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-001111523-0011-1, 11523-0011-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
KAOLIN24H4NWX5COIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STARCH, CORNO8232NY3SJIACT
BENZETHONIUM CHLORIDEPH41D05744IACT
TOLNAFTATE06KB629TKVACTIB

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 Daily PreventionTOLNAFTATEBayer HealthCare LLC.9e8f9211-e85d-725a-e053-2995a90a09b32026-01-16WarningsExact identifier
ndc (package): 11523-0011-2
ndc (package): 11523-0011-1
ndc (product): 11523-0011
ndc11 (package): 11523001102
ndc11 (package): 11523001101
spl id: 48850bbc-9ec2-b7ee-e063-6394a90a9f0d
spl set id: 9e8f9211-e85d-725a-e053-2995a90a09b3

Reported adverse events (FAERS/openFDA)#

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