Lamisil At (terbinafine Hydrochloride) Cream 1% 12 G

Lamisil At (terbinafine Hydrochloride) Cream 1% 12 G
SPL v1
SPL
SPL Set ID 1aa5e03a-432b-4154-ab6e-6dbce7a67109
Route
TOPICAL
Published
Effective Date 2025-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active Since 2025-10-09

Description

Terbinafine hydrochloride 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Terbinafine hydrochloride 1%

Uses
  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Section 50570-1

Do not use

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

For external use only

Directions
  • adults and children 12 years and over:
    • o
      use the tip of the cap to break the seal and open the tube
    • o
      wash the affected skin with soap and water and dry completely before applying
    • o
      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
    • o
      for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
    • o
      wash hands after each use
  • children under 12 years: ask a doctor
Active Ingredient

Terbinafine hydrochloride 1%

Other 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

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

Questions Or Comments?

call 1-888-544-1880

Package Label.principal Display

LAMISILAT

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 12 g (0.42 oz)



RECYCLABLE CARTON



1-888-544-1880



Distributed By:

Karo Healthcare Inc.

Morristown, NJ 07960 USA



Trademarks owned or

licensed By Karo Healthcare



©2025 Karo Healthcare



2005210_1 Made in Canada



LAMISILAT CREAM

TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL

FOR ATHLETE'S FOOT, JOCK ITCH, RINGWORM



NET WT

12g (0.42 oz)



2005211_1


Structured Label Content

Uses
  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)

Do not use

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

Antifungal

Warnings

For external use only

Directions
  • adults and children 12 years and over:
    • o
      use the tip of the cap to break the seal and open the tube
    • o
      wash the affected skin with soap and water and dry completely before applying
    • o
      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
    • o
      for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
    • o
      wash hands after each use
  • children under 12 years: ask a doctor
Active Ingredient

Terbinafine hydrochloride 1%

Other 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

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

Questions Or Comments? (Questions or comments?)

call 1-888-544-1880

Package Label.principal Display (PACKAGE LABEL.PRINCIPAL DISPLAY)

LAMISILAT

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 12 g (0.42 oz)



RECYCLABLE CARTON



1-888-544-1880



Distributed By:

Karo Healthcare Inc.

Morristown, NJ 07960 USA



Trademarks owned or

licensed By Karo Healthcare



©2025 Karo Healthcare



2005210_1 Made in Canada



LAMISILAT CREAM

TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL

FOR ATHLETE'S FOOT, JOCK ITCH, RINGWORM



NET WT

12g (0.42 oz)



2005211_1


Advanced Ingredient Data


Raw Label Data

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