Otc - Active Ingredient
Ketoconazole 1%
Tagrit Antifungal Treament Ketoconazole 1% Cream
FDA Label NDC 85384-0002
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 Tagrit Antifungal Treament Ketoconazole 1% (NDC 85384-0002). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal Ointment
Indications & Usage
Treats fungal infections of the skin, such as folliculitis, athlete's foot, jock itch, ringworm, and seborrheic dermatitis.
Effective for relieving symptoms of itching, scaling, redness, and discomfort caused by fungal infections.
Helps reduce and control fungal skin infections, including tinea corporis (body fungus), tinea cruris (groin fungus), tinea pedis (foot fungus), and tinea versicolor.
Can be used on areas prone to fungal growth, such as the scalp,face,chest, back, arms, and legs.
Warnings
For external use only.
Otc - Do Not Use
on broken, inflamed, or severely irritated skin.
lf you are allergic to Ketoconazole or any other ingredients in this product.
Otc - When Using
Avoid contact with the eyes. If the product gets into the eyes, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if: a rash appears. the condition does not improve within 2-4 weeks of regular use.
Otc - Pregnancy Or Breast Feeding
ask a healthcare provider before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
1. Adults and children 12 years and over:
Clean and dry the affected area before application.
Apply a small amount to the affected area once or twice daily, or as directed by a doctor.
Use continuously for up to 4 weeks, or as directed by a healthcare provider.
2. Children under 12 years:
Ask a doctor before use.
Instructions For Use
Clean the affected area thoroughly with soap and water and dry completely before applying the cream
Apply a small amount of ointment to the affected area and gently rub in.
Use daily for up to 4 weeks, or as directed by a healthcare provider.
Other Safety Information
store at 20°C to 25°C (68°F-77°F).
see the top panel for lot number and expiration date.
Otc - Questions
Questions or comments?
Contact us at: [email protected]
Inactive Ingredient
Borneol
Sophora Flavescens Root
Cnidium monnieri Root
Bassia scoparia Fruit
Scoparia Pollen
Dictamnus Dasycarpus Root
Smilax Glabra Whole
Artemisia argyi Leaf
Tea Tree Oil
Package Label.Principal Display Panel
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