Formula # 39900

Formula # 39900
SPL v3
SPL
SPL Set ID 1fd313ad-a3d9-6c86-e063-6394a90a7ae4
Route
TOPICAL
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Terbinafine (1 g)
Inactive Ingredients
Sorbitan Monostearate Benzyl Alcohol Polysorbate 60 Stearyl Alcohol Water Cetyl Alcohol Sodium Hydroxide Isopropyl Myristate Cetyl Palmitate

Identifiers & Packaging

Marketing Status
NDA Active Since 2024-08-21

Description

Terbinafine hydrochloride 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

- 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

Description

Terbinafine hydrochloride 1%

Section 50565-1

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

Section 50566-9

ask a doctor if too much irritation occurs or gets worse

Section 50567-7

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

Section 50570-1

- on nails or scalp

- in or near the mouth or eyes

- for vaginal yeast infections

Section 51727-6

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

Section 53413-1

call 1-888-544-1880

Section 55105-1

Antifungal

Section 55106-9

Terbinafine hydrochloride 1%

30g (1oz)

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)

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

12g (0.42oz)

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)

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)

Other Information

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

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


Structured Label Content

Indications and Usage (34067-9)

- 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 and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

ask a doctor if too much irritation occurs or gets worse

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

- on nails or scalp

- in or near the mouth or eyes

- for vaginal yeast infections

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

call 1-888-544-1880

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Terbinafine hydrochloride 1%

30g (1oz)

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)

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

12g (0.42oz)

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)

12g New Graphics (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)

Other Information

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

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


Advanced Ingredient Data


Raw Label Data

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