1% KETOCONAZOLE ANTIFUNGAL TREATMENT- antifungal treatment ointment

1% Ketoconazole Antifungal Treatment by

Drug Labeling and Warnings

1% Ketoconazole Antifungal Treatment by is a Otc medication manufactured, distributed, or labeled by Good Manager Holdings Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ketoconazole 1%

Purpose

Antifungal Ointment

Use

1 Treat fungal skin infections such as athlete's foot, jock itch, ringworm, and seborrheic dermatitis.
2. Relieves itching, scaling, and discomfort caused by these fungal infections.

Warnings

For external use only.

Do not use

1. on skin that is broken or inflamed
2. if you are allergic to ingredients in this product

When Using

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

Stop Use

1. if a rash appears or the condition worsens
2. if the condition does not improve in 2-4 weeks.

Ask Doctor

if you are pregnant or breastfeeding.

Keep Oot Of Reach Of Children

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

Directions

Adults and children 12 years and over
1. Apply to the affected area once or twice daily or as directed by a doctor.
2. Wash the affected skin with soap and water and dry completely before applying.
Children under 12 years old. Ask a doctor before use.

Instructions:
1 Clean and dry the affected area before applying the ointment.
2. Apply a small amount of ointment to the affected area and rub in gently.
3. Use daily for up to 4 weeks or as directed by a doctor.

Other information

1. Store at 20°C to 25°C (68°F-77°F)
2. See top panel for lot number and expiration date

Inactive ingredients

Borneol, Sophora Flavescens, Root Cnidium Monnieri, Fruit Kochia, Scopana Pollen, Dictamnus Dasycarpus Root, Smilax Glabra Whole, Artemisia Extract, Tea Tree Oil

Questions

support@tagridllc.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

1% KETOCONAZOLE ANTIFUNGAL TREATMENT 
antifungal treatment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82372-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BORNEOL (UNII: M89NIB437X)
WORMWOOD (UNII: F84709P2XV)
TEA TREE OIL (UNII: VIF565UC2G)
CNIDIUM OFFICINALE ROOT OIL (UNII: 18602BEQ40)
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)
SMILAX GLABRA WHOLE (UNII: H51N91QNEB)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
SCOPINE (UNII: Z5LGM3Q28U)
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82372-012-01	20 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/19/2024

Labeler - Good Manager Holdings Inc (118382673)

Establishment
Name	Address	ID/FEI	Business Operations
Good Manager Holdings Inc		118382673	manufacture(82372-012)