The following Structured Product Label (SPL) was submitted to the FDA by Only Yourx, Inc. for the product Pumice Cleansing Scrub- 2.5% Benzoyl Peroxide (NDC 70367-004). 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 inactive ingredient, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Inactive Ingredients: Water, Sodium C14-16 Alpha Olefin Sulfonate, Microcrystalline Cellulose, Disodium, Cocoamphodiacetate, Glycerin, ethoxydiglycol, Acrylates C10-30 Alkyl Acrylates Crosspolymer, Potassium Sorbate, Polysorbate 20, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol
Active Ingredients: Benzoyl Peroxide 2.5%
Purpose: Acne Medication; a gentle medicated exfoliant wash
Uses: Treats acne and helps prevent new acne blemishes from forming, kills acne bacteria
WARNINGS: For External Use Only
Do not use: if you have very sensitive skin; if you are sensitive to benzoyl peroxide
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 te skin; may bleach hair and fabrics; do not use in or near eyes, lips and mouth
Consult a doctor: if excessive irritation occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
Directions: use 1 to 3 times daily on affected areaws to help prevent breakouts; apply using fingertips, using circular motions; gently scrub into a lather; rinse off thorouhly with warm water; if going outside, use a sunscreen
Other Information: store at room temperature; keep tightly closed
* Please review the disclaimer below.
