Otc - Active Ingredient
Benzoyl Peroxide 5%
Acne Vanishing Gel- 5%
FDA Label NDC 70367-002
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- 5% (NDC 70367-002). 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, otc - purpose, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water, Carbomer, Glycerin, Propylene Glycol, Ethoxydigiycol, Laureth-7, Polyacrylamide C13-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol
Otc - Purpose
Acne Medication
Indications & Usage
treats acne and helps prevent new acne blemishes from forming
kills acne bacteria
Dosage & Administration
Directions:
- Cleanse skin thoroughy 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 other day
- If going outside, use a sunscreen
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
Warnings
WARNINGS: For External Use Only
Other Safety Information
Other Information
- Store at room temperature
- Keep tightly closed
Otc - Do Not Use
Do not use
- If you have very sensitive skin
- If you are sensitive to benzoyl peroxide
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
* Please review the disclaimer below.
