LAMISIL AT CREAM- terbinafine hydrochloride cream

Lamisil AT Cream by

Drug Labeling and Warnings

Lamisil AT Cream by is a Otc medication manufactured, distributed, or labeled by Karo Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

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

Warnings

For external use only

Do not use

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

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

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

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

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

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

INGREDIENTS AND APPEARANCE

LAMISIL AT CREAM 
terbinafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84485-3748
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84485-3748-3	1 in 1 CARTON	11/01/2024
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020980	11/01/2024

Labeler - Karo Healthcare Inc. (119195452)