TAGRIT ANTIFUNGAL TREAMENT KETOCONAZOLE 1%- ketoconazole cream

Tagrit Antifungal Treament Ketoconazole 1% by

Drug Labeling and Warnings

Tagrit Antifungal Treament Ketoconazole 1% by is a Otc medication manufactured, distributed, or labeled by TAGRID LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ketoconazole 1%

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.

on broken, inflamed, or severely irritated skin.

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

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

Stop use and ask a doctor if: a rash appears. the condition does not improve within 2-4 weeks of regular use.

ask a healthcare provider before use.

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.

QUESTIONS

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TAGRIT ANTIFUNGAL TREAMENT KETOCONAZOLE 1% 
ketoconazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85384-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)
TEA TREE OIL (UNII: VIF565UC2G)
BORNEOL (UNII: M89NIB437X)
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
SMILAX GLABRA WHOLE (UNII: H51N91QNEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85384-0002-1	100 g in 1 TUBE; Type 0: Not a Combination Product	04/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/18/2025

Labeler - TAGRID LLC (118778969)