1% Ketoconazole Antifungal Treatment

Manufacturer
Good Manager Holdings Inc
Effective date
2024-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:56:21

Label at a glance#

Product1% Ketoconazole Antifungal Treatment
Active ingredientKETOCONAZOLE
Label structure14 sections

Dosage and administration

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 dail...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal Ointment

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When Using

OTC - WHEN USING SECTION

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

Stop Use

OTC - STOP USE SECTION

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

Ask Doctor

OTC - ASK DOCTOR SECTION

if you are pregnant or breastfeeding.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

support@tagridllc.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82372-01282372-012-01

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

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
2dec9d4e-259c-696d-e063-6394a90a24e32007fe67-b566-84d7-e063-6394a90a9c012025-02-12WarningsExact identifier
spl set id: 2007fe67-b566-84d7-e063-6394a90a9c01

Reported adverse events (FAERS/openFDA)#

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