85398-019 update

Manufacturer
Beautivity LLC
Effective date
2026-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:35

Label at a glance#

ProductHermon Antifungal Soap.
Active ingredientTOLNAFTATE
Label structure9 sections

Storage and handling

Store at room temperature 59°–86°F (15°–30°C).

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

OTC - PURPOSE SECTION

Antifungal

DOSAGE & ADMINISTRATION SECTION

  • For effective treatment of most athlete’s foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris).
  • For effective relief of itching, burning and cracking skin.

INDICATIONS & USAGE SECTION

  • Wash affected area well and let product sit 2–3 minutes before rinsing.
  • Make sure to dry affected area thoroughly.
  • Supervise children in the use of this product.
  • For Athlete’s foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • Use 1–2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

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 avoide contact with eyesIf contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete’s foot and ringworm.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical help or contacta Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Sucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water, Glycerin, Butyrospermum Parkii (Shea) Butter, Lauric Acid, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice, Diospyros Kaki Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Cucurbita Pepo (Pumpkin) Seed Extract, Fragrance

STORAGE AND HANDLING SECTION

Store at room temperature 59°–86°F (15°–30°C).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130199874860732GTIN-13: 0199874860732
EAN-13: 0199874860732
GTIN-12: 199874860732
UPC-A: 199874860732
GTIN storage (14 digits): 00199874860732
antifungal soap label 1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-019-01Hermon Antifungal Soap.232 g in 1 CARTONSOAP2322
85398-019-02Hermon Antifungal Soap.226 g in 1 CARTONSOAP2262

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-01985398-019-01, 85398-019-02

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-10-24monthly-update2026-06-03 17:39:22

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
Hermon Antifungal Soap.TOLNAFTATE 1%Beautivity LLC41e37014-549c-e592-e063-6294a90ac6ab2026-01-17WarningsExact identifier
ndc (package): 85398-019-02
ndc (package): 85398-019-01
ndc (product): 85398-019
ndc11 (package): 85398001901
ndc11 (package): 85398001902
spl id: 489769b9-6479-2174-e063-6294a90ae038
spl set id: 41e37014-549c-e592-e063-6294a90ac6ab

Reported adverse events (FAERS/openFDA)#

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