Active Ingredient(S)
KETOCONAZOLE 1%
Dandrx 1% Ketoconazole Anti-dandruff Liquid
FDA Label NDC 85521-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dandrx Llc for the product Dandrx 1% Ketoconazole Anti-dandruff (NDC 85521-001). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-dandruff
Use
Use: for the control of the symptoms of dandruff and or seborrheic dermatitis.
Warnings
for external use only.
Do Not Use
Do not use on open skin wounds
Otc - When Using
When using this product avoid contact witheyes,if contact occurs. rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Directions: for best results, use every other day or as directed by a doctor.
■ Wet hair thoroughly
■ Massage a liberal amount into your scalp.
■ Leave lather on scalp for several minutes
■ Rinse and repeat
Other Information
Other information: store at room
temperature between 68-78°F(20-25°C).
Do not expose to excessive heat.
Inactive Ingredients
Aqua, Aloe Vera Leaf, Sodium Cocoyl Isethion-ate, Sodium LauroyI Methyl Isethionate, Co-
camidopropyl Hydroxysultaine, Oatmeal, Pan-thenol, Chamomile, Green Tea Leaf, Calendula
Officinalis Flower, Glycerin, Squalane, Cocos Nucifera (Coconut) Oil, Melaleuca Alternifolia
(Tea Tree) Leaf Oil, Azadirachta Indica Flower, Leuconostoc/Radish Root Ferment Filtrate, So-
dium Benzoate, Citric Acid
Package Label - Principal Display Panel
Undefined (Label)
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