FDA.reportPublic FDA data

Athlete Foot Medicated bar

Manufacturer
Beautivity LLC
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:39:59

Label at a glance#

ProductAthlete Foot Medicated bar
Active ingredientTOLNAFTATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

Helps relieve and prevent itching, burning, cracking, and scaling associated with fungal infections such as athlete's foot, jock itch, ringworm, and other skin irritations.

WARNINGS SECTION

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 eyes, if contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask doctor if irritation occurs, there is no improvement within 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Posion Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • Wash affected area & dry thoroughly.
  • Apply a thin layer over affected area twice daily (morning and night).
  • Supervise children in the use of this product.
  • Use daily for 2 weeks.

INACTIVE INGREDIENT SECTION

Aqua (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide

OTHER SAFETY INFORMATION

Store at room temperature. Protect from excessive heat (above 104ºF /40ºC)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

barbar

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1807715tolnaftate 1 % Medicated Bar SoapPSN2
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD2
1807715tolnaftate 1 % Medicated Bar SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-007-01Athlete Foot Medicated bar232 g in 1 CARTONSOAP2322
85398-007-02Athlete Foot Medicated bar116 g in 1 CARTONSOAP1162

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-00785398-007-01, 85398-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM DODECYLBENZENESULFONATE554127163YIACT
TOLNAFTATE06KB629TKVACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
MYRISTIC ACID0I3V7S25AWIACT
SODIUM MYRISTATE06BLC4V0IVIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
SODIUM HYDROXIDE55X04QC32IIACT
HAMAMELIS VIRGINIANA BARKIH3063S9MYIACT
GLYCERINPDC6A3C0OXIACT
LAURIC ACID1160N9NU9UIACT
ELAEIS GUINEENSIS (PALM) OIL5QUO05548ZIACT
SULFUR70FD1KFU70IACT
STEARIC ACID4ELV7Z65APIACT
SODIUM GLUTAMATEW81N5U6R6UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-07-30full-release2026-06-01 01:10:47

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
ndc (package): 85398-007-01
ndc11 (package): 85398000701
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
ndc (package): 85398-007-02
ndc11 (package): 85398000702
Athlete Foot Medicated barTOLNAFTATEBeautivity LLC3b2cedb2-18f4-f571-e063-6394a90a64182025-10-21WarningsExact identifier
ndc (package): 85398-007-02
ndc (package): 85398-007-01
ndc (product): 85398-007
ndc11 (package): 85398000701
ndc11 (package): 85398000702
spl id: 41b1ce91-a894-bc8c-e063-6394a90a4b92
spl set id: 3b2cedb2-18f4-f571-e063-6394a90a6418

Reported adverse events (FAERS/openFDA)#

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