Indications and uses
● cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. ● relieves itching, burning, cracking, and scaling which accompany these conditions
● cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. ● relieves itching, burning, cracking, and scaling which accompany these conditions
● adults and children 12 years and over: ● wash the affected skin with the soap and water and dry completly before applying. ● to open the applicator, twist the base to the ON position. Squeeze tube to dispence cream. ● for athlete's foot between the toes : apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as dire...
Butenafine hydrochloride 1%
Antifungal
● cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
● relieves itching, burning, cracking, and scaling which accompany these conditions
For external use only
Do not use
●
adults and children 12 years and over:
● wash the affected skin with the soap and water and dry completly before applying.
● to open the applicator, twist the base to the ON position. Squeeze tube to dispence cream.
● for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
Childern under 12 years: ask a doctor
● store between 20º to 25º C (68º to 77º F)
Tea Tree Oil, benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83004-016-01 | 2025-08-20 | C162847 | 48780-1 | 3b156c62-2dad-fb37-e063-e6dba90a4e07 | 3a735ca5-4717-43a1-ab42-76f310bcfe00 |
| 83004-016-01 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2dad-fb37-e063-e6dba90a4e07 | 3a735ca5-4717-43a1-ab42-76f310bcfe00 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83004-016 | 83004-016-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TEA TREE OIL | VIF565UC2G | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL STEARATE SE | FCZ5MH785I | IACT |
| CETETH-23 | 495CTZ441V | IACT |
| PROPYLENE GLYCOL DICAPRYLATE | 581437HWX2 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| BUTENAFINE HYDROCHLORIDE | R8XA2029ZI | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 52cf32e6-c512-6fa2-e063-6394a90adb97 | 3a735ca5-4717-43a1-ab42-76f310bcfe00 | 2026-05-27 | Warnings | 3a735ca5-4717-43a1-ab42-76f310bcfe00 |
Adverse event summaries are temporarily unavailable. Other product information remains available.