Indications and uses
cures most athlete's foot (tinea pedis) cures most jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, burning, cracking and scaling which accompany these conditions
cures most athlete's foot (tinea pedis) cures most jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, burning, cracking and scaling which accompany these conditions
adults and children 12 years and older use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. on the bottom or sides of the foot: apply...
do not use if seal on tube is broken or is not visible store at controlled room temperature 20°-25°C (68°-77°F) see carton or tube crimp for lot number and expiration date
Drug Facts
Terbinafine hydrochloride 1%
Antifungal
For external use only
Do not use
When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
| 1 week between the toes 2 weeks on the bottom Or sides of the foot |
benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.
Call 1-877-932-7948
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
| Class | Version | Type | Effective |
|---|---|---|---|
| TERBINAFINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 55a24767-1759-5f6a-8888-ea4aa0adac21 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| db9701af-cb4f-b8ba-d282-6bc5b6b7c467 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 41163-080-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7282-f424-e053-dadaa90a57ce | athlete's foot cream |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41163-080-02 | athletes foot | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 41163-080-02 | athletes foot | 30 g in 1 TUBE | CREAM | 30 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Terbinafine Hydrochloride | ACTIVE INGREDIENT | 012C11ZU6G | 2 | |
| Terbinafine | ACTIVE MOIETY | G7RIW8S0XP | 2 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | 2 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| cetyl palmitate | INACTIVE INGREDIENT | 5ZA2S6B08X | 2 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | 2 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 2 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 2 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | 2 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 41163-080 | 41163-080-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Terbinafine Hydrochloride | 012C11ZU6G | ACTIB |
| benzyl alcohol | LKG8494WBH | IACT |
| cetyl alcohol | 936JST6JCN | IACT |
| cetyl palmitate | 5ZA2S6B08X | IACT |
| isopropyl myristate | 0RE8K4LNJS | IACT |
| polysorbate 60 | CAL22UVI4M | IACT |
| water | 059QF0KO0R | IACT |
| sodium hydroxide | 55X04QC32I | IACT |
| sorbitan monostearate | NVZ4I0H58X | IACT |
| stearyl alcohol | 2KR89I4H1Y | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LOTION, AUGMENTED / TOPICAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVITREAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPERITONEAL | ADJ PH | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TRANSDERMAL | 113 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / RETROBULBAR | ADJ PH | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / OPHTHALMIC | 0.02 %w/v | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAVENOUS | 242 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TRANSDERMAL | 472 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / SUBCUTANEOUS | 225 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SHAMPOO / TOPICAL | 14.55 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM, AUGMENTED / TOPICAL | 6 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IRRIGATION | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER / INTRAVENOUS | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATHECAL | 176 mg | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUPPOSITORY / VAGINAL | NA | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRADERMAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 5.4 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAMUSCULAR | 500 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | SPRAY / NASAL | 5 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPRAY, METERED / NASAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / ENDOTRACHEAL | 54 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / RECTAL | ADJ PH | ||
| cetyl palmitate | CETYL PALMITATE | 5ZA2S6B08X | OINTMENT / TOPICAL | NA | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTERSTITIAL | ADJ PH | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | AEROSOL, FOAM / TOPICAL | 30 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | SUPPOSITORY / RECTAL | 129 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRA-ARTICULAR | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | GEL / VAGINAL | 100 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 144 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 40 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-AMNIOTIC | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACARDIAC | ADJ PH | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / VAGINAL | 200 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / DENTAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBMUCOSAL | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRALESIONAL | 23 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAVENOUS | 45 mg | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | OINTMENT / TOPICAL | NA | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | CAPSULE, EXTENDED RELEASE / ORAL | 72 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / TOPICAL | 2.85 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / VAGINAL | 20 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / RECTAL | 0.05 mg/mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | LOTION / TOPICAL | 4000 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 144 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077511-001 | TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 9b37f48b-1645-43b4-9052-9600e6b7371f | 24e63060-1ac4-4583-8d1b-c595108d0040 | 2015-06-22 | Warnings | 9b37f48b-1645-43b4-9052-9600e6b7371f 24e63060-1ac4-4583-8d1b-c595108d0040 |
Adverse event summaries are temporarily unavailable. Other product information remains available.