FDA Label for 1% Ketoconazole
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- OTC - QUESTIONS
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
1% Ketoconazole Product Label
The following document was submitted to the FDA by the labeler of this product Tagrid Llc. 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.
Otc - Active Ingredient
ketoconazole 1%
Otc - Purpose
Anti Dandruff
Indications & Usage
- Targets Stubborn Dandruff, Seborrheic Dermatitis, and itching
- Prevention, Treatment, and control of fungus that can cause dandruff
Warnings
For external use only
Otc - Do Not Use
on the scalp that is broken or inflamed if you are allergic to ingredients in this product
Otc - When Using
do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
Otc - Stop Use
If the rash appears or the condition worsens does not improve in 2-4 weeks.
Otc - Pregnancy Or Breast Feeding
ask a doctor before use
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Posion Control Center immediately
Dosage & Administration
adults and children
12 years and over
• wet hair thoroughly
• apply shampoo, generously lather, rinse thoroughly. Repeat
• use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff
Children under 12 years old • Ask a doctor
Other Safety Information
• store at 20°C to 25°C (68°F-77°F)
• see top panel for lot number and expiration date
Otc - Questions
Inactive Ingredient
Citric Acid, Herba Violae, Euphorbia Hirta, Murraya Paniculata ,Mentha Canadensis, Sophora Flavescens, Dittany Bark, Glabrous Greenbrier Rhizome, Mosla Cavaleriei Levl ,Stellera Chamaejasme, Huang Bai, Sessile Stemona Root, Gleditsia Sinensis, Common Cnidium Fruit, Fructus Kochiae, Tea Tree Oil, Water
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