Otc - Active Ingredient
Tolnaftate
Tagrid Antifungal Soap
FDA Label NDC 85384-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tagrid Llc for the product Tagrid Antifungal (NDC 85384-0010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses
For effective treatment of jock itch, ringworm, athlete's foot, folliculitnost tinea
For effective relief of itching, burning, and cracking sking skin.
Warnings
For external use only
Otc - Do Not Use
Do not use on children under 2 years of age exceptunder the advice and supervision of a doctor.
Otc - When Using
When using this product avoid contact with the eyes.
Otc - Stop Use
Stop use and ask a doctor if irritation occurs or if there is no improvement within 2weeks for jock itch.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
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
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.
Inactive Ingredient
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
Package Label.Principal Display Panel
Tagrid Antifungal Soap Kit (Antifungal Soap Kit Fixed)
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