initial drug listing-tagrid athlete's foot treament tolnaftate 1%

initial drug listing-tagrid athlete's foot treament tolnaftate 1%
SPL v2
SPL
SPL Set ID 35201d97-23f3-f028-e063-6394a90a9b45
Route
topical
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (10 mg)
Inactive Ingredients
propylene glycol cetyl alcohol white petrolatum sodium benzoate water polysorbate 60 isopropyl myristate phenoxyethanol glyceryl monostearate glycerin triethanolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-30

Description

Tolnaftate 1%


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Tolnaftate 1%

Indications and Usage

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris),and ringworm (tinea corporis)

Relieves itching, buming, cracking,and scaling associated with fungal infections

Dosage and Administration

Direction:

Wash affected area and dry thoroughly

Apply a thin layer of cream over affected area once or twice daily (morning and/or evening)

Use daily for:

· 2 weeks for jock itch 2-4 weeks for athlete's foot and ringworm

Wash hands after use.

Children under 12 years: ask a doctor

Description

Tolnaftate 1%

Section 50565-1

Stop use and ask a doctor if

Condition worsens or does not improve within 3-5 days

Rash, irritation, or other allergic reaction develops

Section 50566-9

Stop use and ask a doctor if

Condition worsens or does not improve within 3-5 days

Rash, irritation, or other allergic reaction develops

Section 50567-7

Avoid contact with eyes.

if irritation occurs, stop use and consult a doctor.

Section 50570-1

Do not use:

On nails or scalp

In the eyes or mouth

For vaginal yeast infections

Section 51727-6

Propylene Glycol, Glycerin, Glyceryl Monostearate, Polysorbate 60, Cetyl Alcohol, White Soft Paraffin, Isopropyl Myristate, Purified Water,Triethanolamine, Phenoxyethanol, Sodium Benzoate

Section 51945-4

Section 53413-1

Questions or comments?

Contact us at:

[email protected]



Distributed by TAGRID LLC

San Francisco, CA, USA 94131

Website: tagridstore.com

Section 55105-1

Antifungal

Section 60561-8

Other Information

Store at 20°-25°C (68°-77°F)

Protect from excessive heat and direct sunlight


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Tolnaftate 1%

Indications and Usage (34067-9)

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris),and ringworm (tinea corporis)

Relieves itching, buming, cracking,and scaling associated with fungal infections

Dosage and Administration (34068-7)

Direction:

Wash affected area and dry thoroughly

Apply a thin layer of cream over affected area once or twice daily (morning and/or evening)

Use daily for:

· 2 weeks for jock itch 2-4 weeks for athlete's foot and ringworm

Wash hands after use.

Children under 12 years: ask a doctor

Section 50565-1 (50565-1)

Stop use and ask a doctor if

Condition worsens or does not improve within 3-5 days

Rash, irritation, or other allergic reaction develops

Section 50566-9 (50566-9)

Stop use and ask a doctor if

Condition worsens or does not improve within 3-5 days

Rash, irritation, or other allergic reaction develops

Section 50567-7 (50567-7)

Avoid contact with eyes.

if irritation occurs, stop use and consult a doctor.

Section 50570-1 (50570-1)

Do not use:

On nails or scalp

In the eyes or mouth

For vaginal yeast infections

Section 51727-6 (51727-6)

Propylene Glycol, Glycerin, Glyceryl Monostearate, Polysorbate 60, Cetyl Alcohol, White Soft Paraffin, Isopropyl Myristate, Purified Water,Triethanolamine, Phenoxyethanol, Sodium Benzoate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Contact us at:

[email protected]



Distributed by TAGRID LLC

San Francisco, CA, USA 94131

Website: tagridstore.com

Section 55105-1 (55105-1)

Antifungal

Section 60561-8 (60561-8)

Other Information

Store at 20°-25°C (68°-77°F)

Protect from excessive heat and direct sunlight


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)