Indications and uses
• cures most jock itch (tinea cruris) and ringworm (tinea corporis) • relieves itching, burning, cracking and scaling which accompany these conditions
• 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 • 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 20-25°C (68-77°F)
Terbinafine hydrochloride 1%
Antifungal
For external use only
do not get into eyes. If eye contact occurs, rinse thoroughly with water.
too much irritation occurs or gets worse
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.
call 1-800-330-9876
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Trademarks owned or licensed by GSK.
©2019 GSK or licensor.
13510 (Front Carton)
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-3999-42 | GM - Gram | 0067-3999 | e2c43041-7171-4b2d-bba5-9a1d2289416f | 1 | 2012-07-24 |
| 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 |
|---|---|
| 0067-3999 | 0067-3999-42 |
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 |
|---|---|---|---|---|---|---|
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | OINTMENT / TOPICAL | 2 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, LIQUID FILLED / ORAL | 1.5 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVASCULAR | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTERIAL | 0.9 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / PERIODONTAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUPPOSITORY / RECTAL | 129 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAMUSCULAR | 225 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT, AUGMENTED / TOPICAL | 0.11 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, FILM COATED / ORAL | 8 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | TABLET / ORAL | 1.06 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, DELAYED RELEASE / ORAL | 0.25 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | DROPS / OPHTHALMIC | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / PARENTERAL | ADJ PH | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TRANSDERMAL | 85 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVENOUS | 78 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY, METERED / NASAL | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRA-ARTICULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVESICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 136.55 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASPINAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAMUSCULAR | 54 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVITREAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUSPENSION / ORAL | 62.5 mg/5ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CREAM, AUGMENTED / TOPICAL | 6 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CAPSULE, EXTENDED RELEASE / ORAL | 72 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTERSTITIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, METERED / RESPIRATORY (INHALATION) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATUMOR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBMUCOSAL | ADJ PH | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / VAGINAL | 425 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPERITONEAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRAMUSCULAR | 40 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRACAVITARY | 0.01 ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INFILTRATION | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAMUSCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / ENDOTRACHEAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVASCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / VAGINAL | 100 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRAVENOUS | 1620 mg | ||
| CETYL PALMITATE | CETYL PALMITATE | 5ZA2S6B08X | OINTMENT / TOPICAL | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, SPRAY / TOPICAL | 6.89 %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 |
|---|---|---|---|---|---|---|---|
| N020980-001 | LAMISIL | TERBINAFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 |
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 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020980-001 | LAMISIL | 1% | CREAM / TOPICAL | RLD, RS | 1999-03-09 | 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 |
|---|---|---|---|---|---|---|
| a39c0cb8-dce2-401e-b52d-e1e7b65ab1fe | 1757a9c4-e989-4f2d-bedc-0ba5137c68dc | 2024-03-25 | Warnings | 1757a9c4-e989-4f2d-bedc-0ba5137c68dc |
Adverse event summaries are temporarily unavailable. Other product information remains available.