SPL v2
SPL
SPL Set ID 39f762a6-9d0c-8ded-e063-6394a90a3659
Route
TOPICAL
Published
Effective Date 2025-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Melaleuca Cajuputi Leaf Oil Eucalyptus Globulus Leaf Oil Rosmarinus Officinalis (rosemary) Leaf Oil Jojoba Oil Cinnamomum Camphora (camphor) Bark Oil Oregano Leaf Oil Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-21

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:47.942017 · Updated: 2026-03-14T23:09:46.965889