gc tolnaftate

gc tolnaftate
SPL v4
SPL
SPL Set ID f9e60430-eec1-4bc2-9522-eb5aa527d90a
Route
topical
Published
Effective Date 2011-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (1 g)
Inactive Ingredients
starch, corn talc

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2011-08-01

Purpose

ANTIFUNGAL

Description

Tolnaftate 1%


Medication Information

Warnings

For external use only

Do not use on children under 2 years of age unless

directed by a doctor.

When using this product avoid contact with the eyes

Stop use and consult a doctor if

• irritation occurs

• there is no improvement within 4 weeks

Uses

• for effective treatment of most athlete’s foot (tinea pedis)

and ringworm (tinea corporis)

• for effective relief of itchy, scaly skin between the toes

• clears up most athlete’s foot infection and with daily

use helps keep it from coming back

Purpose

ANTIFUNGAL

Directions

• shake well before use

• clean the affected area and dry thoroughly

• apply a thin layer of the product over affected area

twice daily (morning and night) or as directed by a doctor

• supervise children in the use of this product

• use daily for 4 weeks. If condition persists longer,

consult a doctor.

For athlete's foot

• pay special attention to the spaces between the toes

• wear well-fitting ventilated shoes

• change shoes and socks at least once daily

• to prevent athlete’s foot, clean and dry feet thoroughly.

Apply as above once or twice daily.

This product is not effective on the scalp or nails.

Other Information

• store at room temperature

Inactive Ingredients

corn starch and talc

Description

Tolnaftate 1%

Package Label

Active Ingredient

Tolnaftate 1%

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control

Center right away.


Structured Label Content

Warnings (WARNINGS)

For external use only

Do not use on children under 2 years of age unless

directed by a doctor.

When using this product avoid contact with the eyes

Stop use and consult a doctor if

• irritation occurs

• there is no improvement within 4 weeks

Uses (USES)

• for effective treatment of most athlete’s foot (tinea pedis)

and ringworm (tinea corporis)

• for effective relief of itchy, scaly skin between the toes

• clears up most athlete’s foot infection and with daily

use helps keep it from coming back

Purpose (PURPOSE)

ANTIFUNGAL

Directions (DIRECTIONS)

• shake well before use

• clean the affected area and dry thoroughly

• apply a thin layer of the product over affected area

twice daily (morning and night) or as directed by a doctor

• supervise children in the use of this product

• use daily for 4 weeks. If condition persists longer,

consult a doctor.

For athlete's foot

• pay special attention to the spaces between the toes

• wear well-fitting ventilated shoes

• change shoes and socks at least once daily

• to prevent athlete’s foot, clean and dry feet thoroughly.

Apply as above once or twice daily.

This product is not effective on the scalp or nails.

Other Information

• store at room temperature

Inactive Ingredients (INACTIVE INGREDIENTS)

corn starch and talc

Package Label (PACKAGE LABEL)

Active Ingredient (Active ingredient)

Tolnaftate 1%

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control

Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)