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.

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 55106-9

Tolnaftate 1%

Section 60561-8

Other Information

Store at 20°-25°C (68°-77°F)

Protect from excessive heat and direct sunlight


Structured Label Content

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

Warnings and Precautions (34071-1)

For external use only.

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 55106-9 (55106-9)

Tolnaftate 1%

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

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