The following Structured Product Label (SPL) was submitted to the FDA by Remeverse for the product So Clear Cleanse Acne Cleanser (NDC 70317-146). 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 so clear cleanse acne cleanser, directions, uses, other, warnings, label, stop use section, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzoyl Peroxide
Water, Disodium Laureth Sulfosuccinate, Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Acrylates Copolymer, Magnesium Aluminum Silicate, Sodium Xylenesulfonate, Montan Wax, Glycolic Acid, Sodium C14-16 Alpha Olefin Sulfonate, Sodium Hydroxide, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol
Acne treatment
Starting with clean hands, apply to face, nose, or ears and gently rub in. Apply 1 -2 times daily. Discontinue use if increased irritation occurs.
for management of acne
Store at room temperature. Avoid high excessive heat. (99 degrees F)
Warnings
For external use only
Do not use this medication if you are sensitive to Benzoyl Peroxide.
When using this product § Avoid unnecessary sun exposure and use a sunscreen. § Avoid contact with eyes, lips and mouth. § Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.
Stop use and ask a doctor if skin irritation becomes severe.
Deleted image of So Clear Cleanse label OTC drug panel (002).jpg and inserted new image of So Clear Cleanse label OTC drug panel (003).jpg So Clear Cleanse label OTC drug panel (003).jpg
This new label change is the name of product at the top of image to SO Clear Cleanse Acne Cleanser
Erased from WARNING SECTION "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." AND added same language removed to OTC - KEEP OUT OF REACHOF CHILDREN section.
Stop use and ask a doctor if skin irritation becomes severe.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
* Please review the disclaimer below.
