FDA.reportPublic FDA data

Update-85398-008-01

Manufacturer
Beautivity LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:36:53

Label at a glance#

ProductAthlete Foot Treatment Kit
Active ingredientTERBINAFINE HYDROCHLORIDE, TOLNAFTATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1% (Soap Bar)

Terbinafine Hydrochloride 1% (Cream)

OTC - PURPOSE SECTION

antifungal

INDICATIONS & USAGE SECTION

Soap Bar

  • 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.

Cream

  • Cures most athlete's foot (tinea pedis)
  • Cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • Relieves itching, burning, cracking and scaling which accompany these conditions

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • on children under 2 years of age unless directed by a doctor
  • on nails and scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

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 a doctor

  • If irritatioin occurs or there is no improvement within 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Soap Bar

  • Wash the affected area thoroughly
  • Allow Hermon Antifungal Soap to sit for 1-2 minutes before rinsing.
  • Dry the area completely after washing.

Cream

  • adults and children 12 years and over
  • use the tip of the cap to break the seal and open the tube
  • wash the affected skin with soap and water and dry completely before applying
  • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
  • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
  • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
  • wash hands after each use
  • children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Do not use if seal on tube is broken or is not visible. Store at room temperature. Protect from excessive heat (above 104°F / 40°C)

INACTIVE INGREDIENT SECTION

Soap Bar
Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), 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

Inactive ingredients

Cream
Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexade- cane, Polysorbate 80, Aloe Barbadensis Leaf Juice, Parfum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kitkit

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130199284956278GTIN-13: 0199284956278
EAN-13: 0199284956278
GTIN-12: 199284956278
UPC-A: 199284956278
GTIN storage (14 digits): 00199284956278		athlete foot kit.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-00885398-008-01
85398-00685398-006-01
85398-00785398-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM ALUM1L24V9R23SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
TERBINAFINE HYDROCHLORIDE012C11ZU6GACTIB
ALLANTOIN344S277G0ZIACT
POLYSORBATE 806OZP39ZG8HIACT
DIMETHICONE92RU3N3Y1OIACT
C12-15 PARETH-73XY03A79QHIACT
ISOHEXADECANE918X1OUF1EIACT
GLYCERINPDC6A3C0OXIACT
ETHYLPARABEN14255EXE39IACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
GLYCERYL STEARATE230OU9XXE4IACT
SODIUM GLUTAMATEW81N5U6R6UIACT
TOLNAFTATE06KB629TKVACTIB
SORBITOL506T60A25RIACT
HAMAMELIS VIRGINIANA BARKIH3063S9MYIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
ELAEIS GUINEENSIS (PALM) OIL5QUO05548ZIACT
WATER059QF0KO0RIACT
SODIUM MYRISTATE06BLC4V0IVIACT
SULFUR70FD1KFU70IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
MYRISTIC ACID0I3V7S25AWIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
LAURIC ACID1160N9NU9UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-02full-release2026-06-01 01:48:20

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): 85398-008-01
ndc (package): 85398-007-01
ndc (package): 85398-006-01
ndc (product): 85398-008
ndc11 (package): 85398000801
ndc11 (package): 85398000701
ndc11 (package): 85398000601
spl id: 5566fc4d-92a2-8e17-e063-6394a90aabe6
spl set id: 3b3aa69f-4e73-cabc-e063-6294a90ab65b
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
ndc (package): 85398-006-01
ndc (product): 85398-006
ndc11 (package): 85398000601
Athlete Foot Medicated barTOLNAFTATEBeautivity LLC3b2cedb2-18f4-f571-e063-6394a90a64182025-10-21WarningsExact identifier
ndc (package): 85398-007-01
ndc (product): 85398-007
ndc11 (package): 85398000701

Reported adverse events (FAERS/openFDA)#

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