Terbinafine Hydrochloride Cream 1% Antifungal Cream

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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 eyes
• for vaginal yeast infections

OTC - WHEN USING SECTION

When using this productdo not get into 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

Directions1 week between the toes Directions2 weeks on the bottom or sides of the foot

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:

Ohm Loaboratories Inc.

New Brunswick, NJ 08901

Made in Canada

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5810

NDC: 50090-5810-0 30 g in a TUBE / 1 in a CARTON

TERBINAFINE HYDROCHLORIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

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

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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