FDA Label for 1% Ketoconazole Antifungal Treatment
View Indications, Usage & Precautions
1% Ketoconazole Antifungal Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Good Manager Holdings Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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