LAMISIL AT TERBINAFINE HYDROCHLORIDE

Manufacturer
Voyant Beauty, Inc.
Effective date
2025-09-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:13:59

Label at a glance#

ProductLAMISIL AT TERBINAFINE HYDROCHLORIDE
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure15 sections

Dosage and administration

- 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 ...

Storage and handling

- do no use if seal on tube is broken or is not visible - store at controlled room temperature 20-25C (68-77F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Terbinafine hydrochloride 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

- cures most athlete's foot (tinea pedis)

- cure most jock itch (tinea cruris) and ringworm (tinea corporis)

- relieves itching, burning, cracking andf scaling which accompany this condition

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

- on nails or scalp

- in or near the mouth or eyes

- for vaginal yeast infections

OTC - WHEN USING SECTION

do not get into eyes. If eye contact occurs, rinse thoroughly with water

OTC - STOP USE SECTION

ask a doctor if too much irritation occurs or gets worse

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:

- 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 twice a day (morning and night) for 2 weeks or as directed by a doctor
- for jock itch and ringworm: 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

Other Information

STORAGE AND HANDLING SECTION

- do no use if seal on tube is broken or is not visible

- store at controlled room temperature 20-25C (68-77F)

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearly alcohol

OTC - QUESTIONS SECTION

call 1-888-544-1880

30g (1oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lamisil AT

Cream

Terbinafine Hydrochloride

Cream 1% - Antifungal

For Athlete's Foot

Relieves Itching

Clinically Proven

to cure most

athelete's foot

between the toes

Fill prescription

strength

NET WT 30 g (1 oz)

new carton 30gnew carton 30g

new tube 30gnew tube 30g

TubeTube

CartonCarton

12g (0.42oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LAMISIL AT

CREAM

TERBINAFINE HYDROCHLORIDE

CREAM 1% - ANTIFUNGAL

FOR JOCK ITCH

CURES MOST

JOCK ITCH

FOR EFFECTIVE

REFLIEF OF ITCHING

AND BURNING

NEW WT 12G (0.42OZ)

TUBE 12gTUBE 12g

CARTON 12gCARTON 12g

12g new graphics

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOW AVAILABEL

LAMISIL AT

CREAM

TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL

ALL-IN-ONE

Athlete's Foot - Jock Itch - Ringworm

Clinically proven to cure most athlete's foot, jock itch, and ringworm

Effective relief of itching, burning, cracking and scaling

Full Prescription Strength

Net wt 12g (0.42oz)

Carton 12g newCarton 12g new

Tube 12g newTube 12g new

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
992530LamISIL AT 1 % Topical CreamPSN3
992528terbinafine HCl 1 % Topical CreamPSN3
992530terbinafine hydrochloride 10 MG/ML Topical Cream [Lamisil]SBD3
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD3
992530Lamisil 10 MG/ML Topical CreamSY3
992530Lamisil AT 1 % Topical CreamSY3
992528terbinafine hydrochloride 1 % Topical CreamSY3

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61047-139-01LAMISIL AT TERBINAFINE HYDROCHLORIDE30 g in 1 TUBECREAM303
61047-139-01LAMISIL AT TERBINAFINE HYDROCHLORIDE1 in 1 CARTONCREAM13
61047-139-02LAMISIL AT TERBINAFINE HYDROCHLORIDE12 g in 1 TUBECREAM123
61047-139-02LAMISIL AT TERBINAFINE HYDROCHLORIDE1 in 1 CARTONCREAM13

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61047-13961047-139-01, 61047-139-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020980-001LAMISILTERBINAFINE HYDROCHLORIDE1%CREAM / TOPICALRLD, RS1999-03-09

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-0984e616aacf4f…
2026-08-18 06:07:402026-07N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-093f01610625f2…
2019-09-15 20:21 UTC2019-09N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020980-001LAMISIL1%CREAM / TOPICALRLD, RS1999-03-09f41ea6bd6efb…

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 AT TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEVoyant Beauty, Inc.1fd313ad-a3d9-6c86-e063-6394a90a7ae42025-09-17WarningsExact identifier
ndc (package): 61047-139-01
ndc (package): 61047-139-02
ndc (product): 61047-139
ndc11 (package): 61047013901
ndc11 (package): 61047013902
spl id: 3f018131-adda-6d1b-e063-6394a90a09f5
spl set id: 1fd313ad-a3d9-6c86-e063-6394a90a7ae4

Reported adverse events (FAERS/openFDA)#

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