Lamisil description, usages, side effects, indications, overdosage, supplying and lots more!

Lamisil

Novartis Consumer Health, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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
    • Directions
      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

    Principal Display

    Principal Display

    Lamisil

    TERBINAFINE HYDROCHLORIDE CREAM

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:0067-6171
    Route of Administration TOPICAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    TERBINAFINE HYDROCHLORIDE Terbinafine 10 mg

    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 Marketing Start Date Marketing End Date
    1 24 in 1 TUBE
    2 NDC:0067-6171-85 1 in 1 CARTON

    Marketing Information

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


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