Otc - Active Ingredient
10 % Benzoyl peroxide
Acne Vanishing Gel-10%
FDA Label NDC 70367-001
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% (NDC 70367-001). 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, inactive ingredient, indications & usage, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
To help with the control of acne
Dosage & Administration
- 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 ther day
- If going outside, use a sunscreen
Warnings
WARNING: For external use only
Inactive Ingredient
Water, Glycerin, Propylene Glycol, Ethoxydiglycol, Cetyl Octanoate, Glyceryl, Stearate, PEG-100 Stearate, Cetearyl Alcohol, Ceteareth-20, Dimthicone, Polysorbate 20, Laureth-7, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Polyacrylamide C3-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenooxyethanol
Indications & Usage
Treats acne and helps prevent new acne blemishes from forming
Kills acne bacteria
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center
Other Safety Information
Store at room temperature
Keep tightly closed
Otc - Ask Doctor
Consult a doctor if excessive irritation occurs
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 medicatons at the same time may cause excessive dryness or irritation of the skin
- may bleach hair and fabrics
- do not use near eyes, lips and mouth
Package Label.Principal Display Panel
Acne Vanishing Gel 10% (20180402 114925)
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