ShopRite

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 1-800-222-1222.

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 footDirections

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?

OTC - QUESTIONS SECTION

Call 1-800-ShopRite

SPL UNCLASSIFIED SECTION

Distributed by: Wakefern Food Corp.
5000 Riverside Drive
Keasbey, NJ 08832

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ShopRite_®

athlete's foot cream
TERBINAFINE HYDROCHLORIDE CREAM, 1%

ANTIFUNGAL CREAM

CURES MOST ATHLETE'S FOOT
FULL PRESCRIPTION STRENGTH
RELIEVES ITCHING & BURNING • RELIEVES CRACKING & SCALING

Net Wt.
0.50 oz (15 g)

DailyMed RxNorm Mappings#

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Products#

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

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

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

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 6 · 302 matching rows.

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

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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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