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

Purpose

Anti-Fungal

Description

Tolnaftate 1%


Medication Information

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.

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.

Purpose

Anti-Fungal

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.

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

Description

Tolnaftate 1%

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

Drug Facts

Active Ingredient

Tolnaftate 1%


Structured Label Content

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.

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.

Purpose

Anti-Fungal

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.

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

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)

Drug Facts

Active Ingredient (Active ingredient)

Tolnaftate 1%


Advanced Ingredient Data


Raw Label Data

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