Terbinafine Hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

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 jock itch (tinea cruris)
• relieves itching, burning, cracking and scaling which accompany this condition

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 eyes
• for vaginal yeast infections

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if too 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
  • 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

STORAGE AND HANDLING SECTION

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR 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 - 12 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cures Most Jock Itch

Full Prescription Strength

Terbinafine Hydrochloride
Cream 1%
Antifungal

NET WT 0.42 oz (12 g)

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

Products#

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

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

• Terbinafine Hydrochloride
• Terbinafine
• benzyl alcohol
• cetyl alcohol
• cetyl palmitate
• isopropyl myristate
• polysorbate 60
• water
• sodium hydroxide
• sorbitan monostearate
• stearyl alcohol

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.