Otc - Active Ingredient
ketoconazole 1%
1% Ketoconazole Shampoo
FDA Label NDC 85384-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tagrid Llc for the product 1% Ketoconazole (NDC 85384-0001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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