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#
Contacts and useful links#
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
OTC - QUESTIONS SECTION
visit us at
www.hermonhealth.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0199284956278 | GTIN-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.
- Hermon Athletes foot Tolnaftate 1% kit
- Tolnaftate 1% kit
- Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream
- tolnaftate 1%
- ALOE VERA LEAF JUICE
- ALCOHOL
- POLYSORBATE 80
- ETHYLPARABEN
- GLYCERYL STEARATE
- DIMETHICONE 6
- ALLANTOIN
- GLYCERIN
- PROPYLENE GLYCOL
- TOLNAFTATE
- ISOHEXADECANE
- HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
- POTASSIUM ALUM
- Athlete Foot Medicated bar
- WATER
- COCOS NUCIFERA (COCONUT) OIL
- STEARIC ACID
- SODIUM GLUTAMATE
- SODIUM MYRISTATE
- MYRISTIC ACID
- SODIUM DODECYLBENZENESULFONATE
- SORBITOL
- MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- LAURIC ACID
- SODIUM HYDROXIDE
- HAMAMELIS VIRGINIANA BARK
- OLEA EUROPAEA (OLIVE) FRUIT OIL
- ELAEIS GUINEENSIS (PALM) OIL
- SULFUR
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85398-018 | 85398-018-01 |
| 85398-017 | 85398-017-02 |
| 85398-007 | 85398-007-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-03-02 | full-release | 2026-06-01 01:48:33 |
| 1 | 2025-10-16 | monthly-update | 2026-06-03 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream | TOLNAFTATE 1% | Beautivity LLC | 4141cca0-1650-6e00-e063-6394a90a13e3 | 2026-06-29 | Warnings | 85398-017-02 85398-017 85398001702 |
| Hermon Athletes foot Tolnaftate 1% kit | TOLNAFTATE 1% KIT | Beautivity LLC | 4142f490-c4b5-a9f3-e063-6394a90ab75e | 2026-06-29 | Warnings | 85398-007-02 85398-018-01 85398-017-02 85398-018 85398001801 85398001702 85398000702 5567639e-1483-121e-e063-6294a90a2eae 4142f490-c4b5-a9f3-e063-6394a90ab75e |
| Athlete Foot Medicated bar | TOLNAFTATE | Beautivity LLC | 3b2cedb2-18f4-f571-e063-6394a90a6418 | 2025-10-21 | Warnings | 85398-007-02 85398-007 85398000702 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
