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LAMISIL AT TERBINAFINE HYDROCHLORIDE

Formula # 39900

Approved
Approval ID

1fd313ad-a3d9-6c86-e063-6394a90a7ae4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Voyant Beauty, Inc.

DUNS: 243547333

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Terbinafine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61047-139
Application NumberNDA020980
Product Classification
M
Marketing Category
C73594
G
Generic Name
Terbinafine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (10)

SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
TERBINAFINE HYDROCHLORIDEActive
Quantity: 1 g in 100 g
Code: 012C11ZU6G
Classification: ACTIB
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/17/2025

12g new graphics

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 new

Tube 12g new

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/21/2024

- 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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/21/2024

Terbinafine hydrochloride 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/21/2024

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 8/21/2024

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/21/2024

- on nails or scalp

- in or near the mouth or eyes

- for vaginal yeast infections

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/21/2024

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/21/2024

ask a doctor if too much irritation occurs or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/21/2024

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/21/2024

Directions

- 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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/21/2024

Other Information

- 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

LOINC: 51727-6Updated: 8/21/2024

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/21/2024

call 1-888-544-1880

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