Lamisil At (terbinafine Hydrochloride) Cream 1% 30 G

Lamisil At (terbinafine Hydrochloride) Cream 1% 30 G
SPL v2
SPL
SPL Set ID 7f8434c2-60c9-4aeb-b0b8-f69107e74609
Route
TOPICAL
Published
Effective Date 2025-01-15
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 2024-11-01

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:
    • 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
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



FOR ATHLETE'S FOOT



RELIEVES ITCHING



CLINICALLY PROVEN TO CURE MOST ATHLETE’S FOOT BETWEEN THE TOES



FULL PRESCRIPTION STRENGTH





NET WT 30 g (1 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.



1-888-544-1880



NDC

84485-3748-3

2004439_1



2003665_1

LAMISILAT CREAM

TERBINAFINE HYDROCHLORIDE  CREAM 1% - ANTIFUNGAL

FOR ATHLETE'S FOOT



NET WT

30g (1 oz)



2004440_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:
    • 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
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



FOR ATHLETE'S FOOT



RELIEVES ITCHING



CLINICALLY PROVEN TO CURE MOST ATHLETE’S FOOT BETWEEN THE TOES



FULL PRESCRIPTION STRENGTH





NET WT 30 g (1 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.



1-888-544-1880



NDC

84485-3748-3

2004439_1



2003665_1

LAMISILAT CREAM

TERBINAFINE HYDROCHLORIDE  CREAM 1% - ANTIFUNGAL

FOR ATHLETE'S FOOT



NET WT

30g (1 oz)



2004440_1


Advanced Ingredient Data


Raw Label Data

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