Tagrit Antifungal Treament Ketoconazole 1%

Manufacturer
TAGRID LLC
Effective date
2025-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:43:31

Label at a glance#

ProductTagrit Antifungal Treament Ketoconazole 1%
Active ingredientKETOCONAZOLE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 1%

OTC - PURPOSE SECTION

Antifungal Ointment

INDICATIONS & USAGE SECTION

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 SECTION

For external use only.

OTC - DO NOT USE SECTION

on broken, inflamed, or severely irritated skin.

lf you are allergic to Ketoconazole or any other ingredients in this product.

OTC - WHEN USING SECTION

Avoid contact with the eyes. If the product gets into the eyes, rinse thoroughly with water.

OTC - STOP USE SECTION

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 SECTION

ask a healthcare provider before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

Questions or comments?
Contact us at: support@tagridllc.com

INACTIVE INGREDIENT SECTION

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

Tagrit Antifungal Treament Ketoconazole 1% Labeling ImageTagrit Antifungal Treament Ketoconazole 1% Labeling Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85384-000285384-0002-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-03-27full-release2026-06-01 00:59:16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsExact identifier
ndc (package): 85384-0002-1
ndc (product): 85384-0002
ndc11 (package): 85384000201
spl id: a42bf040-8183-4a90-bf21-4596f5eacfc5
spl set id: 315a8832-c42f-c07a-e063-6394a90a8218

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.