Initial Drug Listing-tagrid Jock Itch Spray Tolnaftate 1%

Initial Drug Listing-tagrid Jock Itch Spray Tolnaftate 1%
SPL v2
SPL
SPL Set ID 35a98b0c-9558-a464-e063-6294a90ab73e
Route
TOPICAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Glycerin Phenoxyethanol Peg-40 Hydrogenated Castor Oil Polysorbate 80 Polysorbate 20 Sodium Citrate Citric Acid Water Alcohol Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-04

Description

Tolnaftate


Medication Information

Warnings and Precautions

For external use only

Avoid contact with eyes, mouth, or mucous

membranes

Do not apply to broken or irritated skin

Flammable: Keep away from heat and flame

Indications and Usage

■ Cures and prevents most jock itch (tinea cruris)

■ Relieves itching, chafing, and irritation associated with jock itch

■ Helps prevent recurrence when used daily

Dosage and Administration

Directions

Clean the affected area and dry thoroughly.

Shake can well and spray a thin layer over affected area twice daily (morning and night).

Use daily for 2 weeks

Description

Tolnaftate

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor



Condition worsens or does not improve within 2 weeks

Excessive irritation or burning occurs

Section 50570-1

■ on children under 2 years of age unless directed by a doctor

■ for diaper rash

Section 51727-6

Inactive Ingredients:

Alcohol, Propylene Glycol, PEG-40 Hydrogenated,Castor Oil, Polysorbate 20, Polysorbate 80, Glycerin,

Phenoxyethanol, Citric Acid, Sodium Citrate, Purified Water

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

Section 60561-8

Other Information

Store between 20°C to 25°C (68°F to 77°F)

Avoid excessive heat and direct sunlight

Protect from freezing

Do not puncture or incinerate the can


Structured Label Content

Indications and Usage (34067-9)

■ Cures and prevents most jock itch (tinea cruris)

■ Relieves itching, chafing, and irritation associated with jock itch

■ Helps prevent recurrence when used daily

Dosage and Administration (34068-7)

Directions

Clean the affected area and dry thoroughly.

Shake can well and spray a thin layer over affected area twice daily (morning and night).

Use daily for 2 weeks

Warnings and Precautions (34071-1)

For external use only

Avoid contact with eyes, mouth, or mucous

membranes

Do not apply to broken or irritated skin

Flammable: Keep away from heat and flame

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor



Condition worsens or does not improve within 2 weeks

Excessive irritation or burning occurs

Section 50570-1 (50570-1)

■ on children under 2 years of age unless directed by a doctor

■ for diaper rash

Section 51727-6 (51727-6)

Inactive Ingredients:

Alcohol, Propylene Glycol, PEG-40 Hydrogenated,Castor Oil, Polysorbate 20, Polysorbate 80, Glycerin,

Phenoxyethanol, Citric Acid, Sodium Citrate, Purified Water

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

Section 60561-8 (60561-8)

Other Information

Store between 20°C to 25°C (68°F to 77°F)

Avoid excessive heat and direct sunlight

Protect from freezing

Do not puncture or incinerate the can


Advanced Ingredient Data


Raw Label Data

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