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SPL v2

SPL

SPL Set ID 4257ee32-0d8f-08d4-e063-6294a90a4a89

Route

TOPICAL

Published

Effective Date 2025-10-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Undecylenic Acid (1.5 g) Tolnaftate (0.06 g)

Inactive Ingredients

Salicylic Acid Cinnamon Oil Clove Oil Eucalyptus Oil Jojoba Oil Oregano Leaf Oil Tea Tree Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-30

Description

UNDECYLENIC ACID,TOLNAFTATE

Medication Information

Description

UNDECYLENIC ACID,TOLNAFTATE

OREGANO OIL,CLOVE BUD OIL,CINNAMON OIL,JOJOBA SEED OIL,TEA TREE OIL,SALICYLIC ACID,EUCALYPTUS OIL

warnings section

6ml 0.2fl

keep out of reach of children section

Used to remove fungi from the skin or hands and feet

Apply to the affected area every 2 days

Structured Label Content

UNDECYLENIC ACID,TOLNAFTATE

OREGANO OIL,CLOVE BUD OIL,CINNAMON OIL,JOJOBA SEED OIL,TEA TREE OIL,SALICYLIC ACID,EUCALYPTUS OIL

warnings section

6ml 0.2fl

keep out of reach of children section

Used to remove fungi from the skin or hands and feet

Apply to the affected area every 2 days

Advanced Ingredient Data

[{"name": "UNDECYLENIC ACID", "unii": "K3D86KJ24N", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CINNAMON OIL", "unii": "E5GY4I6YCZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OREGANO LEAF OIL", "unii": "7D0CGR40U1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOLNAFTATE", "unii": "06KB629TKV", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"2": "UNDECYLENIC ACID,TOLNAFTATE", "3": "OREGANO OIL,CLOVE BUD OIL,CINNAMON OIL,JOJOBA SEED OIL,TEA TREE OIL,SALICYLIC ACID,EUCALYPTUS OIL", "4": "warnings section", "5": "6ml 0.2fl", "6": "keep out of reach of children section", "7": "Used to remove fungi from the skin or hands and feet", "8": "Apply to the affected area every 2 days"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:26.386350 · Updated: 2026-03-14T23:12:39.597935