Tolnaftate Cream 1% Antifungal Cream

Tolnaftate Cream 1% Antifungal Cream
SPL v8
SPL
SPL Set ID 96a40ccd-17f7-4e4e-98da-207802fa2b2d
Route
TOPICAL
Published
Effective Date 2025-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-09

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

100% GUARANTEED

Cures and Prevents Most Athlete's Foot

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC



www.trifecta-pharma.com

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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 healthcare professional.

Packaging

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 healthcare professional.

● 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

Cetostearyl alcohol, ethylparaben, glycerol, light mineral oil, monostearin, 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)

100% GUARANTEED

Cures and Prevents Most Athlete's Foot

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC



www.trifecta-pharma.com

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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 healthcare professional.

Packaging

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 healthcare professional.

● 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)

Cetostearyl alcohol, ethylparaben, glycerol, light mineral oil, monostearin, petrolatum, purified water, sodium dodecyl sulfate


Advanced Ingredient Data


Raw Label Data

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