Athlete's Foot Cream

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 productdo 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.
• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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 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 Figure 2 weeks on the bottom or sides of the foot 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°-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.

SPL UNCLASSIFIED SECTION

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark ^®

athlete's foot cream

terbinafine hydrochloride cream 1%

antifungal cream

FULL PRESCRIPTION STRENGTH

NET WT 1 oz (30 g)

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

• Athletes Foot
• 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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 302 matching rows.

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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.