Otc - Active Ingredient
Sulfur 10.0%
Roycederm Sulfur Soap. Soap
FDA Label NDC 85424-003
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 Sulfur Soap. (NDC 85424-003). 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, otc - when using, dosage & administration, other safety information, otc - questions, warnings, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne Treatment
Otc - When Using
For the treatment of acne.
Dosage & Administration
Create a rich lather with the mesh bag, gently apply to affected areas, leaving it on the skin for 3 to 5 minutes. Rinse thoroughly with waterand pat dry with a clean towel. Incorporate into your routine 1 to 3 times a day, or as directed by a doctor, for optimal results.
Other Safety Information
Store at room temperature and out of direct sunlight
Otc - Questions
Visit www.roycederm.com
Warnings
- For external use only.
- Apply solely to acne-affected areas.Use caution when combining with other topical acne medications to prevent skin
- irritation and dryness.
- Avoid use on broken or large skin areas.
- Discontinue use and consult a doctor ifexcessive skin irritation occurs.
- When using this product avoid contact with eyes. lf 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 regula ruse as directed.
Otc - Keep Out Of Reach Of Children
lf swallowed, get medical help or contact a Poison Control center(1-800-222-1222) right away.
Inactive Ingredient
Water, Olea Europaea Fruit Oil, 0,25% Salicylic Acid, Lauric Acid, Stearic Acid,Sorbitol,Glycerin, Cocos Nucifera Oil, Elaeis Guineensis Oil, Botanical Acaricide.Potassium Cocoate, Lanolin, Sophor ajaponica Extract, Aloe Extract, Sulfur Spring Extract, Ginseng, Coleus Forskohlii Root Oil, Tea Tree Essential Oil.
Indications & Usage
Uses for the treatment of acne
* Please review the disclaimer below.
