Otc - Active Ingredient
Pyrithione Zinc 2%
Roycederm Seborrheic Dermatitis And Dandruff Medicated Cleansing Bar Soap
FDA Label NDC 85424-008
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 Dandruff Medicated Cleansing Bar (NDC 85424-008). 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
- Anti-dandruff
- Anti-seborrheic dermatitis
Dosage & Administration
Controls and reduces the symptoms of dandruff and seborrheic dermatitis
Warnings
For external use only
Otc - Ask Doctor
you have a conditionthat covers a large area of the body.
Otc - When Using
avoid contact with eyesIf contact occurs, rinse thoroughly with water.
Otc - Stop Use
if condition worsensor does not improve.
Otc - Pregnancy Or Breast Feeding
ask a healthprofessional before use.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)
Indications & Usage
- Cleanse and dry skin.
- Apply a thin layer to affected areas.
- Use thricedaily or as directed by a doctor.
Other Safety Information
store at room temperature.
Inactive Ingredient
Tetrasodium EDTA, Sodium Cocoyl Isethionate, Glycerin, Polyquaternium-7, Menthol, Adep Bovis, Olea Europaea(Olive) fruit Oil, Butyrospermum Parkii (Shea Butter)
Otc - Questions
Email [email protected]
* Please review the disclaimer below.
