Indications and uses
• cures most jock itch (tinea cruris) • relieves itching, burning, cracking and scaling which accompany this condition
• cures most jock itch (tinea cruris) • relieves itching, burning, cracking and scaling which accompany this condition
• 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 • apply once a day (morning or night) for 1 week or as directed by a doctor • wash hands after each use • children under 12 years: ask a doctor
• do not use if seal on tube is broken or is not visible • store at controlled room temperature 20 to 25°C (68 to 77°F)
Drug Facts
Terbinafine hydrochloride 1%
Antifungal
For external use only
When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if too 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
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-8114-12 | GM - Gram | 0067-8114 | 1194084a-343c-46f8-a915-bda58d828f91 | 1 | 2017-03-06 |
| 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 |
|---|---|
| 0067-8114 | 0067-8114-12 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Terbinafine Hydrochloride | 012C11ZU6G | ACTIM |
| 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 | INJECTION / INTRA-AMNIOTIC | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | GUM, CHEWING / BUCCAL | 5 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / ORAL | 125 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | TABLET, FILM COATED / ORAL | 8 mg | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET / ORAL | 20 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IRRIGATION | ADJ PH | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | EMULSION / ORAL | 20 mg/1ml | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRATHECAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | TABLET / ORAL | 10 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | SHAMPOO / TOPICAL | 1.25 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / TOPICAL | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRALESIONAL | 20 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVENOUS | 2.78 %w/v | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRALESIONAL | 23 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | MOUTHWASH / BUCCAL | 2 mg/1ml | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | GEL / RECTAL | 124 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 40 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM, AUGMENTED / TOPICAL | 6 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | OINTMENT / TOPICAL | 2.2 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPLEURAL | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAMUSCULAR | 225 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | DISC / TOPICAL | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAMUSCULAR | 54 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, METERED / RESPIRATORY (INHALATION) | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRAMUSCULAR | 40 mg | ||
| benzyl alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAVENOUS | 45 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVITREAL | ADJ PH | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / TOPICAL | 177 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RECTAL | NA | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVASCULAR | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SHAMPOO / TOPICAL | 3 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, SPRAY / TOPICAL | 6.89 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBCONJUNCTIVAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTERSTITIAL | ADJ PH | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUSPENSION / TOPICAL | 2.15 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | FILM / BUCCAL | 0.09 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / ORAL | 2 mg/5ml | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TRANSDERMAL | 113 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH |
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 |
|---|---|---|---|---|---|---|
| 22fdb154-21bd-4409-bb02-715b75de9d7b | 42401fc5-ae6b-405f-a3c5-7c133be0b02f | 2024-03-25 | Warnings | 42401fc5-ae6b-405f-a3c5-7c133be0b02f |
Adverse event summaries are temporarily unavailable. Other product information remains available.