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Lamisil AT

Generic Name: terbinafine hydrochloride
Dosage Form: cream

Drug Facts

Active ingredient

Terbinafine hydrochloride

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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

1 week between the toes

       • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor

2 weeks on the bottom or sides of the foot

    • 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

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Lamisil AT Cream

LAMISIL  AT
terbinafine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:0067-3998-42 1 TUBE (TUBE) in 1 CARTON
1 12 g in 1 TUBE
2 NDC:0067-3998-30 1 TUBE (TUBE) in 1 CARTON
2 30 g in 1 TUBE
3 NDC:0067-3998-99 42 g in 1 CARTON
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: 01/2010
 
Novartis Consumer Health, Inc.



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