Novonail Solution

Manufacturer
Derma Care Research Labs, LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:45:13

Label at a glance#

ProductNovonail Solution
Active ingredientTOLNAFTATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

For effective treatment of most athlete's foot and ringworm. Relieves itching, scaling, cracking, burning, redness, soreness, 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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN2
313423tolnaftate 10 MG/ML Topical SolutionSCD2
313423tolnaftate 1 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-507-01Novonail Solution13.3 mL in 1 BOTTLE, GLASSLIQUID13.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-507NOVONAIL SOLUTION (TOLNAFTATE 1%) LIQUID [DERMA CARE RESEARCH LABS, LLC]2Current NDC, 1 package rows20241222_013d6107-e3b0-0264-e063-6394a90ae1e2.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
72839-50772839-507-01

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
Novonail SolutionTOLNAFTATE 1%Derma Care Research Labs, LLC013d6107-e3b0-0264-e063-6394a90ae1e22024-12-19WarningsExact identifier
ndc (package): 72839-507-01
ndc (product): 72839-507
ndc11 (package): 72839050701
spl id: 29a5ffca-4dec-43b3-e063-6294a90ac3df
spl set id: 013d6107-e3b0-0264-e063-6394a90ae1e2

Reported adverse events (FAERS/openFDA)#

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