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 over 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...
TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE store at controlled room temperature 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date
Drug Facts
Terbinafine hydrochloride 1%
Antifungal
For external use only
When using this productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.
Stop use and ask a doctor iftoo much irritation occurs or gets worse.
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.
1 877 994 3666Monday to Friday, 8 am to 6 pm Central time.
Distributed by:
Genomma Lab USA Inc., Houston, TX, 77027
Terbinafine Hydrochloride Cream 1% - Antifungal
SILKA ®
ANTIFUNGAL CREAM FOR ATHLETE'S FOOT
Full prescription strength
NET WT.
1 oz (30 g)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1739221 | SILKA 1 % Topical Cream | PSN | 7 |
| 992528 | terbinafine HCl 1 % Topical Cream | PSN | 7 |
| 1739221 | terbinafine hydrochloride 10 MG/ML Topical Cream [Silka Cream] | SBD | 7 |
| 992528 | terbinafine hydrochloride 10 MG/ML Topical Cream | SCD | 7 |
| 1739221 | Silka 1 % Topical Cream | SY | 7 |
| 1739221 | Silka Cream 10 MG/ML Topical Cream | SY | 7 |
| 992528 | terbinafine hydrochloride 1 % Topical Cream | SY | 7 |
| 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 |
| db9701af-cb4f-b8ba-d282-6bc5b6b7c467 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50066-080-02 | Silka Antifungal | 30 g in 1 TUBE | CREAM | 30 | 7 | |
| 50066-080-02 | Silka Antifungal | 1 in 1 CARTON | CREAM | 1 | 7 | |
| 50066-080-03 | Silka Antifungal | 30 g in 1 TUBE | CREAM | 30 | 7 | |
| 50066-080-03 | Silka Antifungal | 1 in 1 CARTON | CREAM | 1 | 7 | |
| 50066-080-05 | Silka Antifungal | 15 g in 1 TUBE | CREAM | 15 | 7 | |
| 50066-080-05 | Silka Antifungal | 1 in 1 CARTON | CREAM | 1 | 7 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Terbinafine Hydrochloride | ACTIVE INGREDIENT | 012C11ZU6G | 1 | |
| Terbinafine | ACTIVE MOIETY | G7RIW8S0XP | 1 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| cetyl palmitate | INACTIVE INGREDIENT | 5ZA2S6B08X | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50066-080 | 50066-080-02, 50066-080-03, 50066-080-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| 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 |
| TERBINAFINE HYDROCHLORIDE | 012C11ZU6G | ACTIM |
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 |
|---|---|---|---|---|---|---|
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / TOPICAL | 177 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / TOPICAL | 177 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / TOPICAL | 177 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| cetyl palmitate | CETYL PALMITATE | 5ZA2S6B08X | CREAM / TOPICAL | 0.32 %w/w | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| cetyl palmitate | CETYL PALMITATE | 5ZA2S6B08X | CREAM / TOPICAL | 0.32 %w/w | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| cetyl palmitate | CETYL PALMITATE | 5ZA2S6B08X | CREAM / TOPICAL | 0.32 %w/w | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / TOPICAL | 177 mg | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| cetyl palmitate | CETYL PALMITATE | 5ZA2S6B08X | CREAM / TOPICAL | 0.32 %w/w |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077511-001 | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | 2007-07-02 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Silka Antifungal | TERBINAFINE HYDROCHLORIDE | Genomma Lab USA, Inc. | a32cf699-e63e-4bd3-a5af-9e1ba447e02e | 2025-07-02 | Warnings | 50066-080-03 50066-080-05 50066-080-02 50066-080 50066008002 50066008003 50066008005 38f62b9e-4081-44e8-e063-6394a90a1f3a a32cf699-e63e-4bd3-a5af-9e1ba447e02e |
Adverse event summaries are temporarily unavailable. Other product information remains available.