LAMISIL

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2021-08-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:38:19

Label at a glance#

ProductLAMISIL AT
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• cures most jock itch (tinea cruris) • relieves itching, burning, cracking, and scaling which accompany this condition

Dosage and administration

• adults and children 12 years and over: • wash the affected area with soap and water and dry completely before applying • to open remove clear cap • hold can 4" to 6" from skin.  Press and hold to spray a thin layer over affected area • spray affected area once a day (morning or night) for 1 week or as directed by a doctor • release to stop spray • wipe excess from spray opening after each use • return cap to can...

Storage and handling

store at 20° to 25° C (68° to 77° F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Terbinafine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most jock itch (tinea cruris)
  • relieves itching, burning, cracking, and scaling which accompany this condition

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
  • do not puncture or incinerate; contents under pressure. Do not expose to heat or store at temperatures above 120ºF (49ºC).

Stop use and ask a doctor if

OTC - STOP USE SECTION

too much irritation occurs or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.  

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over:
    • wash the affected area with soap and water and dry completely before applying
    • to open remove clear cap
    • hold can 4" to 6" from skin.  Press and hold to spray a thin layer over affected area
    • spray affected area once a day (morning or night) for 1 week or as directed by a doctor
    • release to stop spray
    • wipe excess from spray opening after each use
    • return cap to can
    • wash hands after each use
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 20° to 25° C (68° to 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ethanol, polyoxyl 20 cetostearyl ether, propylene glycol, purified water

Questions?

OTC - QUESTIONS SECTION

call 1-800-330-9876

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-6297-01

TERBINAFINE HYDROCHLORIDE SOLUTION 1% - ANTIFUNGAL

LAMISILAT®

SPRAY for JOCK ITCH

Cures most jock itch

For effective relief of itching and burning

Net Contents 125 ml (4.2 fl oz)

1-800-330-9876

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2017 GSK or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

13058

13058_Lamisil AT Spray JI 6297_4.2 oz.JPG
13058_Lamisil AT Spray JI 6297_4.2 oz.JPG

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-62970067-6297-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021124-001LAMISIL ATTERBINAFINE HYDROCHLORIDE1%SOLUTION / TOPICALRLD, RS2000-03-17
N021124-002LAMISIL ATTERBINAFINE HYDROCHLORIDE1%SPRAY / TOPICALRLD, RS2000-03-17

Observed Orange Book product history#

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1784e616aacf4f…
2026-09-14 22:38:342026-08N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1784e616aacf4f…
2026-08-18 06:07:402026-07N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021124-001LAMISIL AT1%SOLUTION / TOPICALRLD, RS2000-03-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021124-002LAMISIL AT1%SPRAY / TOPICALRLD, RS2000-03-1774a2ff9319b5…

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8c14f66a-df25-4477-b92e-f2e508acdb93a262ea43-d9c5-4574-8ba9-2bb3c09e81602024-03-25WarningsExact identifier
spl set id: a262ea43-d9c5-4574-8ba9-2bb3c09e8160

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.