Quality Choice Antifungal Cream Tolnaftate 1%

Quality Choice Antifungal Cream Tolnaftate 1%
SPL v1
SPL
SPL Set ID 26303499-dc58-f417-e063-6394a90a0a1b
Route
TOPICAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Mineral Oil Ethylparaben Glycerin Sodium Lauryl Sulfate Glyceryl Monostearate Petrolatum Water Cetyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-14

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses

● proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) ● helps prevent most athlete's foot with daily use ● for effective relief of itching, burning and cracking.

Label

Warnings

For external use only.

When using this productavoid contact with the eyes.

Stop use and ask a doctorl if● irritation occurs ● there is no improvement within 4 weeks improvement

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Directions

● wash affected area and dry thoroughly

● apply a thin layer over affected area twice daily (morning and night)

● supervise children in the use of this product

● for athlete’s foot: pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily.

● use daily for 4 weeks; if conditions persists longer, ask a doctor.

● to prevent athlete's foot, apply once or twice daily (morning and/or night)

● this product is not effective on the scalp or nails.

Drug Facts

Distributed By

Distributed by CDMA, Inc.

Novi, MI. 48375

www.qualitychoice.com

Questions 800-935-2362

This product is not manufactured or distributed by Bayer Health Care, LLC. distributor of Tinactin® Antifungal Cream.

Active Ingredient

Tolnaftate 1%

Other Information

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

Inactive Ingredients

Cetyl alcohol, ethylparaben, glycerol, mineral oil, glycerol monostearate, petrolatum, purified water, sodium lauryl sulfate

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

● proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) ● helps prevent most athlete's foot with daily use ● for effective relief of itching, burning and cracking.

Label

Purpose

Antifungal

Warnings

For external use only.

When using this productavoid contact with the eyes.

Stop use and ask a doctorl if● irritation occurs ● there is no improvement within 4 weeks improvement

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Directions

● wash affected area and dry thoroughly

● apply a thin layer over affected area twice daily (morning and night)

● supervise children in the use of this product

● for athlete’s foot: pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily.

● use daily for 4 weeks; if conditions persists longer, ask a doctor.

● to prevent athlete's foot, apply once or twice daily (morning and/or night)

● this product is not effective on the scalp or nails.

Drug Facts

Distributed By

Distributed by CDMA, Inc.

Novi, MI. 48375

www.qualitychoice.com

Questions 800-935-2362

This product is not manufactured or distributed by Bayer Health Care, LLC. distributor of Tinactin® Antifungal Cream.

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

Inactive Ingredients (Inactive ingredients)

Cetyl alcohol, ethylparaben, glycerol, mineral oil, glycerol monostearate, petrolatum, purified water, sodium lauryl sulfate

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)