Update-85398-018-01

Manufacturer
Beautivity LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:37:07

Label at a glance#

ProductHermon Athletes foot Tolnaftate 1% kit
Active ingredientTOLNAFTATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

  • Soap Bar: Tolnaftate 1%
  • Cream: Tolnaftate 1%

OTC - PURPOSE SECTION

Antifungal

DOSAGE & ADMINISTRATION SECTION

  • cures most athlete's foot (tinea pedis)
  • cures most jock itch(tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accomppany these conditions
  • For effective relief of itching, cirritation, redness, scaling, cracking, burning, soreness, anddiscomfort which can 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 or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - ASK DOCTOR SECTION

if irritation occurs or there is no improvement within 2 wveeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Directions (Cream)

  • adults and children 12 years and over
  • use the tip of thecap to break the seal and open the tube
  • wash the affedted 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 ttoes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
  • on the bottom or sides ofthe foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
  • for jock itch and ringworm: apply oncea 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
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for2 weeks


Directions (Soap Bar)

  • Wet skin with warm water and lather soap.
  • Gently massage onto affeected areas.
  • Rinse thoroughly and dry.
  • Use twice daily or as directed by 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

Cream:

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyc Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurrate Copolymer, Isohexadecane, Polysorbate 80, Aloe Barbadensis Leaf Juice

Soap Bar:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

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
package.jpg

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-01885398-018-01
85398-01785398-017-02
85398-00785398-007-02

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-02full-release2026-06-01 01:48:33
12025-10-16monthly-update2026-06-03 17:38:24

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
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate CreamTOLNAFTATE 1%Beautivity LLC4141cca0-1650-6e00-e063-6394a90a13e32026-06-29WarningsExact identifier
ndc (package): 85398-017-02
ndc (product): 85398-017
ndc11 (package): 85398001702
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
ndc (package): 85398-007-02
ndc (package): 85398-018-01
ndc (package): 85398-017-02
ndc (product): 85398-018
ndc11 (package): 85398001801
ndc11 (package): 85398001702
ndc11 (package): 85398000702
spl id: 5567639e-1483-121e-e063-6294a90a2eae
spl set id: 4142f490-c4b5-a9f3-e063-6394a90ab75e
Athlete Foot Medicated barTOLNAFTATEBeautivity LLC3b2cedb2-18f4-f571-e063-6394a90a64182025-10-21WarningsExact identifier
ndc (package): 85398-007-02
ndc (product): 85398-007
ndc11 (package): 85398000702

Reported adverse events (FAERS/openFDA)#

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