Lamisil AT Cream

Manufacturer: Karo Healthcare Inc.
Effective date: 2025-01-09
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:53:10

Label at a glance#

ProductLamisil AT Cream

Active ingredientTERBINAFINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

cures most jock itch (tinea cruris) relieves itching, burning, cracking and scaling which accompany these conditions

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 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

Contacts and useful links#

PhoneLabel contact1-888-544-1880

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 these conditions

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.

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:
- 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

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-544-1880

12 g Tube with Carton - For Jock Itch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LAMISIL^AT
CREAM

TERBINAFINE HYDROCHLORIDE
CREAM 1% - ANTIFUNGAL

for JOCK ITCH

► CURES MOST JOCK ITCH
► FOR EFFECTIVE RELIEF OF ITCHING AND BURNING

NET WT 12 g (0.42 oz)

RECYCLABLE CARTON

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

Made in Canada

Trademarks owned or
licensed by Karo Healthcare

©2024 Karo Healthcare
or licensor.

Karo
healthcare

Questions or
comments?
call 1-888-544-1880

NDC
84485-3607-1
2004313_1

2004314_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
992530	LamISIL AT 1 % Topical Cream	PSN	1
992528	terbinafine HCl 1 % Topical Cream	PSN	1
992530	terbinafine hydrochloride 10 MG/ML Topical Cream [Lamisil]	SBD	1
992528	terbinafine hydrochloride 10 MG/ML Topical Cream	SCD	1
992530	Lamisil 10 MG/ML Topical Cream	SY	1
992530	Lamisil AT 1 % Topical Cream	SY	1
992528	terbinafine hydrochloride 1 % Topical Cream	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TERBINAFINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
55a24767-1759-5f6a-8888-ea4aa0adac21	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84485-3607-1	Lamisil AT Cream	1 in 1 CARTON	CREAM	1		1
84485-3607-1	Lamisil AT Cream	12 g in 1 TUBE	CREAM	12		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84485-3607	LAMISIL AT CREAM (TERBINAFINE HYDROCHLORIDE) CREAM [KARO HEALTHCARE INC.]	1	Current NDC, 2 package rows	20250120_0f59271d-997f-4dcc-aae3-900b53df1c95.zip

Products#

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

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

Lamisil AT Cream
Terbinafine Hydrochloride
TERBINAFINE
CETYL ALCOHOL
POLYSORBATE 60
STEARYL ALCOHOL
BENZYL ALCOHOL
CETYL PALMITATE
ISOPROPYL MYRISTATE
WATER
SODIUM HYDROXIDE
SORBITAN MONOSTEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84485-3607	84485-3607-1

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
TERBINAFINE HYDROCHLORIDE	012C11ZU6G	ACTIB
CETYL ALCOHOL	936JST6JCN	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CETYL PALMITATE	5ZA2S6B08X	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT

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-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 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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamisil AT Cream	TERBINAFINE HYDROCHLORIDE	Karo Healthcare Inc.	0f59271d-997f-4dcc-aae3-900b53df1c95	2025-01-09	Warnings	Exact identifier ndc (package): 84485-3607-1 ndc (product): 84485-3607 ndc11 (package): 84485360701 spl id: dc1dfa6d-7d6d-43cf-a25a-8497e3430bcd spl set id: 0f59271d-997f-4dcc-aae3-900b53df1c95

Reported adverse events (FAERS/openFDA)#

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