Label

Label
SPL v6
SPL
SPL Set ID be71b8a6-3a5f-0be9-e053-2a95a90a1c40
Route
TOPICAL
Published
Effective Date 2021-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Tolnaftate 1%


Medication Information

Warnings and Precautions

For External Use Only

Indications and Usage

. For effective treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) . Relieves itching, scaling, irritation, and discomfort . Clears up most athlete's foot infection and helps keep it from coming back with daily use

Dosage and Administration

. Shake well before using . Clean the affected area and dry thoroughly . Apply a thin layer of product over the affected area twice a day (morning and night) or as directed by a doctor . Supervise children in the use of this product . This product is not effective on the scalp or nails

Description

Tolnaftate 1%

Section 44425-7

Store between 2°-30ºC (36°-86°F)

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Section 50566-9

. Irritation occurs . There is no improvement within 4 weeks

Section 50567-7

Avoid contact with the eyes

Section 50570-1

On children under 2 years of age

Section 51727-6

Talc, Corn Starch

Section 51945-4

CR-371081 IN MASTER

Section 53413-1

1-800-645-2158

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%


Structured Label Content

Indications and Usage (34067-9)

. For effective treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) . Relieves itching, scaling, irritation, and discomfort . Clears up most athlete's foot infection and helps keep it from coming back with daily use

Dosage and Administration (34068-7)

. Shake well before using . Clean the affected area and dry thoroughly . Apply a thin layer of product over the affected area twice a day (morning and night) or as directed by a doctor . Supervise children in the use of this product . This product is not effective on the scalp or nails

Warnings and Precautions (34071-1)

For External Use Only

Section 44425-7 (44425-7)

Store between 2°-30ºC (36°-86°F)

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Section 50566-9 (50566-9)

. Irritation occurs . There is no improvement within 4 weeks

Section 50567-7 (50567-7)

Avoid contact with the eyes

Section 50570-1 (50570-1)

On children under 2 years of age

Section 51727-6 (51727-6)

Talc, Corn Starch

Section 51945-4 (51945-4)

CR-371081 IN MASTER

Section 53413-1 (53413-1)

1-800-645-2158

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%


Raw Label Data

All Sections (JSON)