SPL v4
SPL
SPL Set ID a0ae6ab7-960d-4fed-ab31-fb70882fc7e0
Route
TOPICAL
Published
Effective Date 2017-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 mg)
Inactive Ingredients
Dimethyl Isosorbide Isopropyl Alcohol Isopropyl Myristate Lactic Acid Ethyl Acetate Urea Undecylenic Acid Propylene Glycol Jojoba Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-12-16

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses

Cures most Athlete’s Foot (Tinea Pedis) ■ Relieves itching, cracking, burning and scaling, which accompanies this condition ■

Prevents recurrence of Athlete’s Foot

Section 51945-4

Warnings

Keep out of reach of children

Directions

Wash the affected area with soap and water.

■ Dry thoroughly, then apply a thin layer over the affected area.

■ Use twice daily (morning and night) or as directed by a physician.

■ Pay special attention to the spaces between the toes and the areas around the edges and under the front of the nails.

■ Wear well-fitted ventilated shoes and change socks at least once daily.

■ Use daily for four (4) weeks. If condition persists longer, consult a physician.

■ Wash hands after each use. Store and use at room temperature.

Active Ingredient

Tolnaftate 1%

Inactive Ingredeints

Inactive Ingredients: Ethyl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol, Water

Cosmetic Ingredients: Urea, Lactic Acid, Jojoba Oil, Undecylenic Acid, Dimethyl Isosorbide, Vitamin E


Structured Label Content

Uses

Cures most Athlete’s Foot (Tinea Pedis) ■ Relieves itching, cracking, burning and scaling, which accompanies this condition ■

Prevents recurrence of Athlete’s Foot

Section 51945-4 (51945-4)

Purpose

Antifungal

Warnings

Keep out of reach of children

Directions

Wash the affected area with soap and water.

■ Dry thoroughly, then apply a thin layer over the affected area.

■ Use twice daily (morning and night) or as directed by a physician.

■ Pay special attention to the spaces between the toes and the areas around the edges and under the front of the nails.

■ Wear well-fitted ventilated shoes and change socks at least once daily.

■ Use daily for four (4) weeks. If condition persists longer, consult a physician.

■ Wash hands after each use. Store and use at room temperature.

Active Ingredient

Tolnaftate 1%

Inactive Ingredeints

Inactive Ingredients: Ethyl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol, Water

Cosmetic Ingredients: Urea, Lactic Acid, Jojoba Oil, Undecylenic Acid, Dimethyl Isosorbide, Vitamin E


Advanced Ingredient Data


Raw Label Data

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