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

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Terbinafine Hydrochloride

Preferred Pharmaceuticals, Inc

Terbinafine Hydrochloride Cream 1% Antifungal Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Terbinafine Hydrochloride 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 the eyes
  • •for vaginal yeast infections

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

Stop use and ask a doctor if

  • •too much irritation occurs or gets worse.
  • •side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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 older
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

    1 week between the toes

    2 weeks on the bottom or sides of the foot

    Terbinafine Hydrochloride 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)
    • •see carton or tube crimp for lot number and expiration date

    Inactive ingredients

    benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

    How Supplied

    Terbinafine Hydrochloride Cream 1% is available in 15gm tubes - 68788-9814-1

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

    Relabeled By Preferred Pharmaceuticals, Inc

    PRINCIPAL DISPLAY PANEL

    Terbinafine Hydrochloride

    Terbinafine Hydrochloride CREAM

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:68788-9814(NDC:51672-2080)
    Route of Administration TOPICAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    TERBINAFINE HYDROCHLORIDE Terbinafine 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
    WHITE

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-9814-1 15 in 1 TUBE

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077511 2012-04-05


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    Be sure to consult your doctor before taking any medication!
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