OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Tolnaftate 1%
Active ingredient
Tolnaftate 1%
Purpose
Anti-fungal
Uses
Warnings
For external use only
- do not use on children under 2 years of age unless directed by a doctor
Extremely flammable
• keep away from fire or flame
When using this product
• avoid contact with the eyes
• if contact occurs rinse thoroughly with water
Stop use and ask a doctor if
• irritation occurs and there is no improvement in 4 weeks
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
■ shake well before using ■ wash affected area and dry thoroughly ■ apply a thin layer of the
product over affected area (around the nails and underneath nail tips) twice daily or as directed
by a doctor ■ supervise children in the use of this product ■ 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 ■ for athlete’s foot and ringworm, use daily for 4 weeks. If condition
persists longer, consult a doctor ■ this product is not effective on the scalp or nails
• store at room temperature 15° - 30°C (59°-86°F)
Inactive ingredients
Acetone, Aloe Vera (Aloe Barbadensis) Gel, Propylene Glycol, Tocopherol Acetate (Vitamin E), Water
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68975-181-02 | 2023-07-28 | C162847 | 48780-1 | f386c64a-19b7-0266-e053-dadaa90a7c1a | bc4c3911-bfd1-4b49-930e-01983f6bb01f |
| 68975-181-02 | 2023-01-30 | C162847 | 48780-1 | f386c64a-19b7-0266-e053-dadaa90a7c1a | bc4c3911-bfd1-4b49-930e-01983f6bb01f |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68975-181 | 68975-181-01, 68975-181-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Tolnaftate | 06KB629TKV | ACTIB |
| ACETONE | 1364PS73AF | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 018e11ca-b26c-9d94-e063-6294a90a3df2 | bc4c3911-bfd1-4b49-930e-01983f6bb01f | 2023-07-28 | Warnings | bc4c3911-bfd1-4b49-930e-01983f6bb01f |
Adverse event summaries are temporarily unavailable. Other product information remains available.