Antifungal Cream Tolnaftate 1%

Antifungal Cream Tolnaftate 1%
SPL v5
SPL
SPL Set ID 915759af-0d7f-6a87-e053-2a95a90acbd6
Route
TOPICAL
Published
Effective Date 2019-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-30

Description

Tolnaftate 1%

Purpose

Anti-Fungal


Medication Information

Purpose

Anti-Fungal

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.

Section 42229-5

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

500 VOLVO PARKWAY, CHESAPEAKE, VA. 23320

NOT SATISFIED?

Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

This product is not manufactured or distributed by Bayer, owner of the registered trademark Tinactin®

Section 51945-4

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a healthcare professional 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

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, light mineral oil, glycerol monostearate, petrolatum, purified water, sodium dodecyl sulfate


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.

Section 42229-5 (42229-5)

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

500 VOLVO PARKWAY, CHESAPEAKE, VA. 23320

NOT SATISFIED?

Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

This product is not manufactured or distributed by Bayer, owner of the registered trademark Tinactin®

Section 51945-4 (51945-4)

Purpose

Anti-Fungal

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a healthcare professional 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

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, light mineral oil, glycerol monostearate, petrolatum, purified water, sodium dodecyl sulfate


Advanced Ingredient Data


Raw Label Data

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