Af Foam Clear Skin Acne Pore Cleanser
FDA Label NDC 50544-301

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by University Medical Pharmaceuticals Corp for the product Af Foam Clear Skin Acne Pore Cleanser (NDC 50544-301). 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 - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Benzoyl Peroxide 2.5% w/v

Otc - Purpose

Purpose: Acne Treatment

Indications & Usage

Use for the treatment of acne.

Warnings

Warnings For external use only.

Otc - Do Not Use

Do not use: If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use: If you are using other topical acne drugs at the same time or right before use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.

Otc - When Using

When using this product:
  • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
  •  Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid product with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Otc - Stop Use

Stop use and ask a doctor: If excessive irritation occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions
  • Use AM and PM. Recommended: After AM use, follow with AcneFree All-Day Acne Control. After PM use, follow with 3-in-1 Acne Night Repair.
  • Moisten skin.
  • Shake well before each use.
  • Hold Can upright and press down firmly on dispenser. Apply a small amount of foam (not more than a dollop the size of a gold ball) into hand.
  • Using fingers, apply to face and gently massage to cleanse.
  • Rinse thoroughly with warn water and pat dry.
  • If bothersome peeling occurs, reduce application use.
  • If going outside, use a sunscreen.

Inactive Ingredient

Inactive ingredients: Benzylkonium Chloride, Caprylic/Capric Triglyceride, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Decyl Glucoside, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Glycerin,  Glyceryl Sterate, Isobutane, Magnesium Aluminum Silicate, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propane, Sea Whip Extract, Sodium Benzoate, Sodium Polyacrylate, Stearic Acid, Water, Xanthan Gum.

Storage And Handling

Other Information
  • Store at 60o-85oF (15o-30oC).
  • Pressurized container: protect from sunlight and do not expose to temperatures exceeding 120oF(49oC). Do not puncture or birn, even after use. Use only as directed.

Package Label.Principal Display Panel

AcneFree Clear Skin treatmentsOil-Free Acne Pore CleanserMicro-Benzoyl Peroxide 2.5%Rinse-Off Foam Medicine Stays in Pores Even After Rinsing

* Please review the disclaimer below.