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Tagrid Antifungal

Initial Drug Listing-Tagrid Antifungal Soap Kit

Approved
Approval ID

3663e054-9411-358a-e063-6394a90af6b4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

TAGRID LLC

DUNS: 118778969

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolnaftate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85384-0010
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (12)

GLEDITSIA SINENSIS FRUITInactive
Code: A6W0J6UO7Q
Classification: IACT
MENTHA CANADENSIS WHOLEInactive
Code: J1BO4MHT2L
Classification: IACT
TOLNAFTATEActive
Quantity: 10 mg in 1 g
Code: 06KB629TKV
Classification: ACTIB
STELLERA CHAMAEJASME WHOLEInactive
Code: 80N0P0DD9J
Classification: IACT
OATMEALInactive
Code: 8PI54V663Y
Classification: IACT
SOPHORA FLAVESCENS ROOTInactive
Code: IYR6K8KQ5K
Classification: IACT
PHELLODENDRON CHINENSE WHOLEInactive
Code: QKA3ZK8IIE
Classification: IACT
CNIDIUM MONNIERI FRUITInactive
Code: V1IA3S3CUS
Classification: IACT
STEMONA SESSILIFOLIA ROOTInactive
Code: EKG8030U4N
Classification: IACT
EUCALYPTUS GLOBULUS LEAF OILInactive
Code: 2R04ONI662
Classification: IACT
DICTAMNUS DASYCARPUS ROOT BARKInactive
Code: LA97176ILS
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/9/2025

Tagrid Antifungal Soap Kit

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/9/2025

Uses
For effective treatment of jock itch, ringworm, athlete's foot, folliculitnost tinea
For effective relief of itching, burning, and cracking sking skin.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/9/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/9/2025

Tolnaftate

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/9/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 6/9/2025

For external use only

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor if irritation occurs or if there is no improvement within 2weeks for jock itch.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/9/2025

DIRECTIONS
Wash the affected area well and let the product sit for 1-2 minutes before rising
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.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/9/2025

The cream provided is intended for severe cases, and 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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/9/2025

If you have any questions about this product, please contact us at support@tagridllc.com, or visit www.tagridllc.com for more information.
Tested and designed in the USA.

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Tagrid Antifungal - FDA Drug Approval Details