lamisil at (terbinafine hydrochloride) cream 1% 12g

lamisil at (terbinafine hydrochloride) cream 1% 12g
SPL v1
SPL
SPL Set ID 0f59271d-997f-4dcc-aae3-900b53df1c95
Route
topical
Published
Effective Date 2025-01-09
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 2025-01-20

Purpose

Antifungal

Description

Terbinafine hydrochloride 1%


Medication Information

Warnings

For external use only

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

Antifungal

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
    • 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
  • 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

Description

Terbinafine hydrochloride 1%

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
Active Ingredient

Terbinafine hydrochloride 1%

Questions Or Comments?

call 1-888-544-1880

12 G Tube With Carton for Jock Itch

LAMISILAT

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


Structured Label Content

Warnings

For external use only

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

Antifungal

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
    • 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
  • 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

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
Active Ingredient

Terbinafine hydrochloride 1%

Questions Or Comments? (Questions or comments?)

call 1-888-544-1880

12 G Tube With Carton for Jock Itch (12 g Tube with Carton - For Jock Itch)

LAMISILAT

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)