Otc - Active Ingredient
Salicylic Acid USP
Roycederm Seborrheic Dermatitis And Psoriasis Shampoo. Shampoo
FDA Label NDC 85424-020
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 Dermatitis And Psoriasis Shampoo. (NDC 85424-020). 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 - 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
Seborrheic dermatitis and psoriasis
Dosage & Administration
Relieves and helps prevent recurrence of scalp: itching, flaking, scaling, redness, and irritation associated with psoriasis and seborrheic dermatitis.
Warnings
For external use only.
Otc - Ask Doctor
condition covers a large area of the body.
Otc - When Using
Avoid contact with eyes. If contact occurs, rinse the eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if
condition worsens or does not improve after regular use as directed
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medicaladvice immediately or contact a Poison Control Center right away. (1-800-222-1222)
Indications & Usage
- Apply shampoo & massage into the scalp.
- Leave in hair for 3-5 minutes to allow maximum absorption.
- Rinse and repeat as needed.
- Use daily for best results.
- Do not use it on children under 12 years of age unless directed by a doctor.
Other Safety Information
Store at room temperature and out of direct sunlight
Inactive Ingredient
Water, Disodium EDTA, Citric acid, SodiumCitrate, Plantapon L61l, ChembetaineCAD, Lamesoft PO65, Glycerin, Zemea Propanediol, Chlorhexidine gluconate,Sodium Benzoate, Dex Panthenol,Polyquaternium-44, Calendula extract,Chamomile extract
Otc - Questions
Visit www.roycederm.com
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