FDA.reportPublic FDA data

Aftate Athlete Foot Cream

Manufacturer
Sabel Med LLC
Effective date
2016-11-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:23

Label at a glance#

ProductAftate Athlete Foot Cream
Active ingredientTOLNAFTATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient-USAActive Ingredient-USA

DOSAGE & ADMINISTRATION SECTION

tolnaftate dosage directions USAtolnaftate dosage directions USA

INACTIVE INGREDIENT SECTION

tolnaftate inactive USAtolnaftate inactive USA

WARNINGS SECTION

tolnaftate warnings USAtolnaftate warnings USA

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Tolnaftate keep out of reachTolnaftate keep out of reach

OTC - PURPOSE SECTION

tolnaftate purpose USAtolnaftate purpose USA

INDICATIONS & USAGE SECTION

tolnaftate usage USAtolnaftate usage USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tolnaftate pdp USAtolnaftate pdp USA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN2
103951tolnaftate 10 MG/ML Topical CreamSCD2
103951tolnaftate 1 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70356-001-01Aftate Athlete Foot Cream28 g in 1 TUBECREAM282
70356-001-05Aftate Athlete Foot Cream14 g in 1 TUBECREAM142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70356-001AFTATE ATHLETE FOOT CREAM (TOLNAFTATE) CREAM [SABEL MED LLC]2Current NDC, Legacy NDC, 2 package rows20170106_2aa58a66-e00b-74c9-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70356-00170356-001-01, 70356-001-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
TOLNAFTATE06KB629TKVACTIB
CETYL ALCOHOL936JST6JCNIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)9Q5W5G6461IACT
PROPYLPARABENZ8IX2SC1OHIACT
CHLOROCRESOL36W53O7109IACT
CETETH-20I835H2IHHXIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT

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
Aftate Athlete Foot CreamTOLNAFTATESabel Med LLC2aa58a66-e00b-74c9-e054-00144ff88e882016-11-23WarningsExact identifier
ndc (package): 70356-001-05
ndc (package): 70356-001-01
ndc (product): 70356-001
ndc11 (package): 70356000105
ndc11 (package): 70356000101
spl id: 42b2fcc6-ec9f-543f-e054-00144ff8d46c
spl set id: 2aa58a66-e00b-74c9-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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