SPL v1
SPL
SPL Set ID 445354d8-bec2-0fd9-e063-6394a90a0099
Route
TOPICAL
Published
Effective Date 2025-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Water Panthenol Triethanolamine Terpinen 4-propionate Lactic Acid Polyethylene (4-(trifluoromethoxy)phenyl)urea Carbomer Polyacrylamide (10000 Mw) Glycerin Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-24
Description

Tolnaftate

Medication Information

Warnings and Precautions

keep out of reach of children

Indications and Usage

PUREE Pure Nailtific Extra-Strength Fungal Nail Patches

Dosage and Administration

32 Patches+1 Nail File

Description

Tolnaftate

Section 50565-1

keep out of reach of children

Section 51727-6

Water,Glycerol/Glycerin,Polyethylene,Carbomer,Triethanolamine,Sodium Polyacrylate,Polyacrylamide,Urea,Urea,Seaweed Extract,Panthenol,Tocopheryl Acetate

Section 51945-4

Section 55105-1

PUREE Pure Nailtific Extra-Strength Fungal Nail Patches

Section 55106-9

Tolnaftate

Structured Label Content

Indications and Usage (34067-9)

PUREE Pure Nailtific Extra-Strength Fungal Nail Patches

Dosage and Administration (34068-7)

32 Patches+1 Nail File

Warnings and Precautions (34071-1)

keep out of reach of children

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Water,Glycerol/Glycerin,Polyethylene,Carbomer,Triethanolamine,Sodium Polyacrylate,Polyacrylamide,Urea,Urea,Seaweed Extract,Panthenol,Tocopheryl Acetate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PUREE Pure Nailtific Extra-Strength Fungal Nail Patches

Section 55106-9 (55106-9)

Tolnaftate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:19.756160 · Updated: 2026-03-14T23:10:38.535907