Otc - Active Ingredient
Salicylic Acid 2.0%
Roycederm Seborrheic Scalp .spray. Spray
FDA Label NDC 85424-028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Roycederm Seborrheic Scalp .spray. (NDC 85424-028). 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, dosage & administration, warnings, otc - ask doctor, 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
Otc - Purpose
Anti-Seborrheic Dermatitis, Antidandruff
Dosage & Administration
- controls the symptom of seborrheic dermatitis.
- helps prevent recurrence of skin and scalp itching,irritation, redness, flaking, scaling associated with seborrheic dermatitis
Warnings
For external use only.
Otc - Ask Doctor
if you have a condition that covers a large area of the body.
Otc - When Using
avoid contact with the eye. If contact occurs, rinse the eyes thoroughly with water.
Otc - Stop Use
Stop 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 right away.
Indications & Usage
Adults and children 12 years & older:
- apply to affected areas one to four times daily or as directed by a doctor.
- spray directly onto the affected scalp area.
- massage gently if needed.
- do not rinse.
Other Safety Information
Store at room temperature and out of direct sunlight.
Inactive Ingredient
Water, Propanediol, Tromethamine,Butylene Glycol, PEG-40 Hydrogenated Castor Oil, Dipotassium Glycyrrhizate, Panthenol, Aloe Barbadensis Extract, Decyloxazolidi-none, Melaleuca Alternifolia (TeaTree) Leaf Oil, Laurylpyridinium Chloride, Glycerin, 1,2-Hexanediol,Crocus Sativus Flower Extract,Swertia Bimaculata Extract, Avena Sativa (Oat) Kernel Extract, Pullulan,Hydroxyacetophenone, Gentiana Scabra Extract, Gentiana Macrophyl-la Extract, Allantoin, Lavandula Angustifolia (Lavender) Oil, Citric Acid, Cyclodextrin, Niacinamide,Caffeine, Centella Asiatica Extract,Biotin, Hamamelis Virginiana (WitchHazel) Extract, Rosmarinus Officinalis (Rosemary) Extract.
Otc - Questions
Visit www.roycederm.com
Tel: +1(307) 461 0958
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