Warnings
WARNINGS: For External Use Only
Acne Vanishing Gel- 10% With Sulfur
FDA Label NDC 70367-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Only Yourx, Inc. for the product Acne Vanishing Gel- 10% With Sulfur (NDC 70367-003). 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 warnings, otc - active ingredient, indications & usage, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients:
Benzoyl Peroxide 10%
Sulfur 3%
Indications & Usage
Treats acne and helps prevent new blemishes from forming
Kills acne bacteria
Otc - Do Not Use
Do Not Use: if you have very sensitive skin
are sensitive to benzoyl peroxide or sulfur
Otc - When Using
When using this product
avoid sun exposure and use sunscreen
using other acne medications at the same time may cause excessive dryness or irritation of the skin
may bleach hair and fabrics
do not use in or near eyes, lips and mouth
Otc - Ask Doctor
Consult a doctor if excessive irritation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
Dosage & Administration
Directions:
cleanse skin thoroughly before applying
cover entire affected area with thin layer 1 to 3 times daily
if excessive dryness or irritation occurs, reduce application to once a day or every oter day
if going outside, use a sunscreen
Other Safety Information
Other information
store at room temperature
keep tightly closed
Inactive Ingredient
Inactive Ingredients:
Water, Ethoxydiglycol, Cetyl Octanoate, Glyceryl Stearate, APEG-100 Stearate, Glycerin, Propylene Glycol, Cetearyl Alcohol, Ceteareth-20, Polyacrylamide C13-14 Isoparaffin, Laureth-7, Dimethicone, Potassium Sorbate, Polysorbate 20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Phenoxyethanol
Otc - Purpose
To treat acne and reduce inflammation
* Please review the disclaimer below.
