Otc - Active Ingredient
Active Ingredients: Sulfur 10%
Soothing Antiseptic Mask With Sulfur
FDA Label NDC 70367-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Only Yourx, Inc. for the product Soothing Antiseptic Mask With Sulfur (NDC 70367-010). 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, inactive ingredient, dosage & administration, indications & usage, otc - purpose, warnings, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients: Water, Kaolin, Bentonite, Glycerin, Propylene Glycol, Magnesium Aluminum Silicate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Potassium Sorbate, Ethyl hexylglycerin, Phenoxyethanol
Dosage & Administration
Directions: apply thin coat over affe3cted area; leave on approximately 20 minutes until completely dry; rinse off with warm watre; use recommended toner to finish cleansing; purified water may be added for smoothr mask consistency
Indications & Usage
Uses: treats acne and helps prevent new acne blemishes from forming
Otc - Purpose
acne mediaction; to treat and prevent acne
Warnings
Warnings: For External Use Only
Otc - When Using
When using this product: do not use in or near eyes, lips, and mouth
Otc - Ask Doctor
Consult a doctor: if excessive irritation occurs
Other Safety Information
Other information: store at room temperature; keep tightly closed
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
* Please review the disclaimer below.
