Lamisil AT (Terbinafine Hydrochloride) Spray 1% 120 g

Manufacturer
Karo Healthcare Inc.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:36

Label at a glance#

ProductLamisil AT
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure8 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...

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if too much irritation occurs or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

OTHER SAFETY INFORMATION

  • 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 or comments?

OTC - QUESTIONS SECTION

call 1-888-544-1880

PACKAGE LABEL.PRINCIPAL DISPLAY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LAMISILAT
SPRAY
TERBINAFINE HYDROCHLORIDE
SOLUTION 1% - ANTIFUNGAL

FOR JOCK ITCH

►CURES MOST JOCK ITCH

►FOR EFFECTIVE RELIEF OF ITCHING AND BURNING

NET WT 4.20Z (120g)

1-888-544-1880

Distributed By:
Karo Healthcare Inc.
Morristown, NJ 07960 USA

Trademarks owned or licensed
by Karo Healthcare

©2024 Karo Healthcare or licensor

2004104_1

Can-Label
Can-Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
992536LamISIL AT 1 % Topical SprayPSN1
992535terbinafine HCl 1 % Topical SprayPSN1
992536terbinafine hydrochloride 10 MG/ML Topical Spray [Lamisil]SBD1
992535terbinafine hydrochloride 10 MG/ML Topical SpraySCD1
992536Lamisil 1 % Topical SpraySY1
992536Lamisil 10 MG/ML Topical SpraySY1
992536Lamisil AT 1 % Topical SpraySY1
992535terbinafine hydrochloride 1 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TERBINAFINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84485-3606-4Lamisil AT120 g in 1 CANSPRAY1201

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
84485-360684485-3606-4

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
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.d3e75665-e2d4-47d9-baaa-93817b5fbf002025-12-12WarningsExact identifier
ndc (package): 84485-3606-4
ndc (product): 84485-3606
ndc11 (package): 84485360604
spl id: d3e75665-e2d4-47d9-baaa-93817b5fbf00
spl set id: d3e75665-e2d4-47d9-baaa-93817b5fbf00

Reported adverse events (FAERS/openFDA)#

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