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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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 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 Directions 2 weeks on the bottom or sides of the foot Directions

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°-25°C (68°-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 or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
RUGBY LABORATORIES
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Terbinafine Hydrochloride

GENERIC: Terbinafine Hydrochloride

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0670-0

COLOR: white

PACKAGING: 30 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

• Terbinafine Hydrochloride 1g in 100g

INACTIVE INGREDIENT(S):

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

Remedy_Label

DailyMed Billing Units#

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#

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.

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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