Otc - Active Ingredient
Benzoyl Peroxide 2.5%
Benzoyl Peroxide
FDA Label NDC 84339-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Enrich Enterprises Xiamen Limited for the product Benzoyl Peroxide (NDC 84339-001). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne Treatment
Indications & Usage
Use For the treatment of acne.
Warnings
- For external use only.
Otc - Do Not Use
Do not use if you
- Are sensitive to benzoyl peroxide.
Otc - When Using
When using this product
- Avoid unnecessary sun exposure and use an SPF.
-Avoid contact with the eyes, lips, mouth and hair.
- Skin irritation, redness, burning, itching or peeling may occur.
- Only use one topical acne medication at a time as skin irritation and dryness is more likely to occur.
- Keep out of reach of children.
-If swallowed get medical help or call poison control center immediately.
Otc - Stop Use
- If swallowed get medical help or call poison control center immediately.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
Dosage & Administration
- Clean the skin gently before applying this product.
- Cover the affected area with a fingertip unit of product once or twice daily.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive Ingredient
Other Ingredients: Water, Propanediol, Glycerin, Carbomer, Sodium Phytate, Sodium Hydroxide
Package Label.Principal Display Panel
84339-001-01 (84339 001 01)
* Please review the disclaimer below.
