Initial Drug Listing - Initial Drug Listing - Tagrid Athlete's Foot Spray Tolnaftate 1%

Initial Drug Listing - Initial Drug Listing - Tagrid Athlete's Foot Spray Tolnaftate 1%
SPL v2
SPL
SPL Set ID d3c514e7-9913-4f8d-87ff-777563bec237
Route
TOPICAL
Published
Effective Date 2025-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Water Propylene Glycol Glycerin Tea Tree Oil Sophora Flavescens Root Calendula Officinalis Flower Artemisia Vulgaris Root Bassia Scoparia Fruit Mentha Canadensis Top Phellodendron Amurense Bark Polysorbate 20 Polyoxyl 40 Hydrogenated Castor Oil Phenoxyethanol Ethylhexylglycerin Citric Acid Monohydrate Disodium Hydrogen Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-10

Description

Active ingredient: Tolnaftate 1%


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

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.
Dosage and Administration

Directions:

  • Clean the affected area and dry thoroughly.
  • Spray a thin layer over affected area twice daily (morning and night).
  • For athlete’s foot: pay special attention to the spaces between the toes; wear well-fitting, breathable shoes, and change socks daily. Allow shoes to dry out between uses.
Description

Active ingredient: Tolnaftate 1%

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 if

  • Condition worsens or does not improve within 2 weeks.
  • Excessive irritation or burning occurs.
Section 50567-7

When using this product

  • Avoid contact with eyes.
  • Use only as directed.
  • If irritation occurs, stop use and consult a doctor.
Section 50570-1

Do not use:

  • On children under 2 years of age unless directed by a doctor.
  • For diaper rash.
Section 51727-6

Inactive ingredients:

  • Water
  • Artemisia vulgaris extract
  • Kochia scoparia fruit extract
  • Dictamnus dasycarpus root extract
  • Smilax glabra root extract
  • Solidago decurrens fruiting top extract
  • Phellodendron amurense bark extract
  • Euphorbia fischeriana root extract
  • Gleditsia sinensis fruit extract
  • Stemona tuberosa root extract
Section 53413-1

Questions or comments?

Contact us at [email protected]

Section 55105-1
  • Antifungal
Section 55106-9

Active ingredient:

  • Tolnaftate 1%
Section 60561-8
  • Store between 20°C to 25°C (68°F to 77°F).
  • Avoid excessive heat and direct sunlight.
  • Protect from freezing.
Package Label.principal Display Panel

Available in 100 mL, 50 mL and 30 mL can. All packages look the same externally, with the only variation being fill volume.


Structured Label Content

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

Directions:

  • Clean the affected area and dry thoroughly.
  • Spray a thin layer over affected area twice daily (morning and night).
  • For athlete’s foot: pay special attention to the spaces between the toes; wear well-fitting, breathable shoes, and change socks daily. Allow shoes to dry out between uses.
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 if

  • Condition worsens or does not improve within 2 weeks.
  • Excessive irritation or burning occurs.
Section 50567-7 (50567-7)

When using this product

  • Avoid contact with eyes.
  • Use only as directed.
  • If irritation occurs, stop use and consult a doctor.
Section 50570-1 (50570-1)

Do not use:

  • On children under 2 years of age unless directed by a doctor.
  • For diaper rash.
Section 51727-6 (51727-6)

Inactive ingredients:

  • Water
  • Artemisia vulgaris extract
  • Kochia scoparia fruit extract
  • Dictamnus dasycarpus root extract
  • Smilax glabra root extract
  • Solidago decurrens fruiting top extract
  • Phellodendron amurense bark extract
  • Euphorbia fischeriana root extract
  • Gleditsia sinensis fruit extract
  • Stemona tuberosa root extract
Section 53413-1 (53413-1)

Questions or comments?

Contact us at [email protected]

Section 55105-1 (55105-1)
  • Antifungal
Section 55106-9 (55106-9)

Active ingredient:

  • Tolnaftate 1%
Section 60561-8 (60561-8)
  • Store between 20°C to 25°C (68°F to 77°F).
  • Avoid excessive heat and direct sunlight.
  • Protect from freezing.
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Available in 100 mL, 50 mL and 30 mL can. All packages look the same externally, with the only variation being fill volume.


Advanced Ingredient Data


Raw Label Data

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