LAMISIL AT - terbinafine hydrochloride cream 
Novartis Consumer Health, Inc.

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Drug Facts

Active ingredient

Terbinafine hydrochloride

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 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 not 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

call 1-800-452-0051

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008

Principal display panel

LAMISIL  AT terbinafine hydrochloride   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-3998 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   CETYL ALCOHOL   CETYL PALMITATE   ISOPROPYL MYRISTATE   POLYSORBATE 60   WATER   SODIUM HYDROXIDE   SORBITAN MONOSTEARATE   STEARYL ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0067-3998-85 1 TUBE In 1 CARTON contains a TUBE 1 24 g In 1 TUBE This package is contained within the CARTON (0067-3998-85) 2 0067-3998-42 1 TUBE In 1 CARTON contains a TUBE 2 12 g In 1 TUBE This package is contained within the CARTON (0067-3998-42) 3 0067-3998-15 1 TUBE In 1 CARTON contains a TUBE 3 15 g In 1 TUBE This package is contained within the CARTON (0067-3998-15) 4 0067-3998-28 1 TUBE In 1 CARTON contains a TUBE 4 28 g In 1 TUBE This package is contained within the CARTON (0067-3998-28) 5 0067-3998-30 1 TUBE In 1 CARTON contains a TUBE 5 30 g In 1 TUBE This package is contained within the CARTON (0067-3998-30) 6 0067-3998-40 1 TUBE In 1 CARTON contains a TUBE 6 40 g In 1 TUBE This package is contained within the CARTON (0067-3998-40) 7 0067-3998-36 36 g In 1 TUBE None 8 0067-3998-43 42 g In 1 TUBE None 9 0067-3998-54 54 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020980	08/10/2005

Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 01/2010Novartis Consumer Health, Inc.