Athlete's Foot Cream

Label at a glance#

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.

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 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 1 2 weeks on the bottom or sides of the foot figure 2

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 PUBLIX
SUPER MARKETS, INC.
3300 PUBLIX CORPORATE
PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Publix

athlete'sfootcream

1% TERBINAFINE HYDROCHLORIDE,
ANTIFUNGAL CREAM

CURES MOST ATHLETE'S FOOT

NET WT 1 OZ (30g)

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

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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#

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

Source Document#

Source XML

Inactive ingredient matches#

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Inactive ingredient links page 1 of 1 · 16 matching rows.

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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#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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