Initial Drug Listing-tagrid Antifungal Soap

Initial Drug Listing-tagrid Antifungal Soap
SPL v3
SPL
SPL Set ID 7aa42827-59c2-4926-a3a2-e60dd219eb41
Route
TOPICAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Gleditsia Sinensis Fruit Mentha Canadensis Whole Stellera Chamaejasme Whole Oatmeal Sophora Flavescens Root Phellodendron Chinense Whole Cnidium Monnieri Fruit Stemona Sessilifolia Root Eucalyptus Globulus Leaf Oil Dictamnus Dasycarpus Root Bark Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-09

Description

Tolnaftate


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses

For effective treatment of jock itch, ringworm, athlete's foot, folliculitnost tinea

For effective relief of itching, burning, and cracking sking skin.

Dosage and Administration

DIRECTIONS

  • Wash the affected area well and let the product sit for 1-2 minutes before rinsing.
  • Ensure thorough drying of the affected area.
  • Supervise children when using this product.
  • For patients seeking immediate relief or experiencing severe symptoms, we recommend applying the ointment.
  • Please note the potential burning and stinging sensation after application, primarily due to menthol and other natural ingredients.
  • Endure any discomfort for 5-10 minutes before experiencing immediate relief.
  • Use 1-2 times daily for 4 weeks. If the condition persists longer, consult a doctor.
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 if irritation occurs or if there is no improvement within 2weeks for jock itch.

Section 50567-7

When using this product avoid contact with the eyes.

Section 50570-1

Do not use on children under 2 years of age exceptunder the advice and supervision of a doctor.

Section 51727-6

Ingredients:

  • GLEDITSIA SINENSIS FRUIT
  • MENTHA CANADENSIS WH LE
  • STELLERA CHAMAEJASME WHOLE
  • OATMEAL
  • SOPHORA FLAVESCENS ROOT
  • PHELLODENDRON CHINENSE WHOLE
  • CNIDIUM MONNIERI FRUIT
  • STEMONA SESSILIFOLIA ROOT
  • EUCALYPTUS GLOBULUS LEAF OIL
  • DICTAMNUS DASYCARPUS ROOT BARK
  • MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
Section 51945-4

Available in 1 bar per box and 2 bars per box.

Section 53413-1

If you have any questions about this product, please contact us at [email protected], or visit www.tagridllc.com for more information.

Tested and designed in the USA.

Section 55106-9

Tolnaftate

Section 60561-8

Users may experience a burning or stinging sensation upon application. This discomfort should be tolerated for 5-10 minutes before subsiding and can be relieved immediately.


Structured Label Content

Indications and Usage (34067-9)

Uses

For effective treatment of jock itch, ringworm, athlete's foot, folliculitnost tinea

For effective relief of itching, burning, and cracking sking skin.

Dosage and Administration (34068-7)

DIRECTIONS

  • Wash the affected area well and let the product sit for 1-2 minutes before rinsing.
  • Ensure thorough drying of the affected area.
  • Supervise children when using this product.
  • For patients seeking immediate relief or experiencing severe symptoms, we recommend applying the ointment.
  • Please note the potential burning and stinging sensation after application, primarily due to menthol and other natural ingredients.
  • Endure any discomfort for 5-10 minutes before experiencing immediate relief.
  • Use 1-2 times daily for 4 weeks. If the condition persists longer, consult a doctor.
Warnings and Precautions (34071-1)

For external use only

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 irritation occurs or if there is no improvement within 2weeks for jock itch.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age exceptunder the advice and supervision of a doctor.

Section 51727-6 (51727-6)

Ingredients:

  • GLEDITSIA SINENSIS FRUIT
  • MENTHA CANADENSIS WH LE
  • STELLERA CHAMAEJASME WHOLE
  • OATMEAL
  • SOPHORA FLAVESCENS ROOT
  • PHELLODENDRON CHINENSE WHOLE
  • CNIDIUM MONNIERI FRUIT
  • STEMONA SESSILIFOLIA ROOT
  • EUCALYPTUS GLOBULUS LEAF OIL
  • DICTAMNUS DASYCARPUS ROOT BARK
  • MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
Section 51945-4 (51945-4)

Available in 1 bar per box and 2 bars per box.

Section 53413-1 (53413-1)

If you have any questions about this product, please contact us at [email protected], or visit www.tagridllc.com for more information.

Tested and designed in the USA.

Section 55106-9 (55106-9)

Tolnaftate

Section 60561-8 (60561-8)

Users may experience a burning or stinging sensation upon application. This discomfort should be tolerated for 5-10 minutes before subsiding and can be relieved immediately.


Advanced Ingredient Data


Raw Label Data

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