Dermatool Fungal Nail Treatment

Manufacturer
Papalo Group LLC | Derma Care Research Labs, LLC
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:15

Label at a glance#

ProductDermatool Fungal Nail Treatment
Active ingredientTOLNAFTATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning, redness, sorenes, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

WARNINGS SECTION

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Stop use and ask a doctor if: irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. This product is not effective for the treatment of ringworm of the scalp or nails. For athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

INACTIVE INGREDIENT SECTION

Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Oryza Sativa (Rice) Bran Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Simmondsia Chinensis (Jojoba) Seed Oil, BHT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN1
313423tolnaftate 10 MG/ML Topical SolutionSCD1
313423tolnaftate 1 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84728-510-01Dermatool Fungal Nail Treatment1 in 1 CARTONLIQUID11
84728-510-01Dermatool Fungal Nail Treatment15 mL in 1 BOTTLE, GLASSLIQUID151
84728-510-02Dermatool Fungal Nail Treatment2 in 1 BOXLIQUID21
84728-510-02Dermatool Fungal Nail Treatment15 mL in 1 BOTTLE, GLASSLIQUID151
84728-510-03Dermatool Fungal Nail Treatment15 mL in 1 BOTTLE, GLASSLIQUID151
84728-510-03Dermatool Fungal Nail Treatment3 in 1 BOXLIQUID31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84728-510DERMATOOL FUNGAL NAIL TREATMENT (TOLNAFTATE 1%) LIQUID [PAPALO GROUP LLC]1Current NDC, 6 package rows20250204_2d2c0e12-123d-75bd-e063-6394a90ae546.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84728-51084728-510-01, 84728-510-02, 84728-510-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Papalo Group LLC2d2c0e12-123d-75bd-e063-6394a90ae5462025-01-31WarningsExact identifier
ndc (package): 84728-510-03
ndc (package): 84728-510-02
ndc (package): 84728-510-01
ndc (product): 84728-510
ndc11 (package): 84728051001
ndc11 (package): 84728051002
ndc11 (package): 84728051003
spl id: 2d2c0e12-123e-75bd-e063-6394a90ae546
spl set id: 2d2c0e12-123d-75bd-e063-6394a90ae546

Reported adverse events (FAERS/openFDA)#

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