Terbinafine Hydrochloride

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SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Terbinafine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor iftoo much irritation occurs or gets worse.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 footwear 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 weekor as directed by a doctor
    • on the bottom or sides of the foot:apply twice a day (morning and night) for 2 weeksor as directed by a doctor
  • for jock itch and ringworm:apply once a day (morning ornight) for 1 weekor 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
Figure		Figure

Other information

STORAGE AND HANDLING SECTION

• do not use if seal on tube is broken or is not visible
• store at controlled room temperature 20° to 25°C (68° to 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cures Most Ringworm
Full Prescription Strength

Terbinafine Hydrochloride
Cream 1%

Antifungal Cream

NET WT ½ oz (15 g)

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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

• Terbinafine Hydrochloride
• BENZYL ALCOHOL
• CETYL ALCOHOL
• CETYL PALMITATE
• ISOPROPYL MYRISTATE
• POLYSORBATE 60
• WATER
• SODIUM HYDROXIDE
• SORBITAN MONOSTEARATE
• STEARYL ALCOHOL
• TERBINAFINE

NDC Codes#

Ingredients#

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Product history page 1 of 2 · 43 observed states.

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