445354d8-bec2-0fd9-e063-6394a90a0099

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

Active Ingredient

Tolnaftate

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

Structured Label Content

Warnings and Precautions (34071-1)

keep out of reach of children

Active Ingredient (55106-9)

Tolnaftate

Indications and Usage (34067-9)

PUREE Pure Nailtific Extra-Strength Fungal Nail Patches

Dosage and Administration (34068-7)

32 Patches+1 Nail File

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

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOLNAFTATE", "unii": "06KB629TKV", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "TRIETHANOLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TERPINEN 4-PROPIONATE", "unii": "EZJ56UOJ4C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTIC ACID", "unii": "33X04XA5AT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE", "unii": "UG00KM4WR7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "(4-(TRIFLUOROMETHOXY)PHENYL)UREA", "unii": "SQP4E8O29W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYACRYLAMIDE (10000 MW)", "unii": "E2KR9C9V2I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM POLYACRYLATE (8000 MW)", "unii": "285CYO341L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "PUREE Pure Nailtific Extra-Strength Fungal Nail Patches", "34068-7": "32 Patches+1 Nail File", "34071-1": "keep out of reach of children", "50565-1": "keep out of reach of children", "51727-6": "Water,Glycerol/Glycerin,Polyethylene,Carbomer,Triethanolamine,Sodium Polyacrylate,Polyacrylamide,Urea,Urea,Seaweed Extract,Panthenol,Tocopheryl Acetate", "55105-1": "PUREE Pure Nailtific Extra-Strength Fungal Nail Patches", "55106-9": "Tolnaftate"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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