Af Foam Sensitive Acne Pore Cleanser
FDA Label NDC 50544-304

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 Sensitive Acne Pore Cleanser (NDC 50544-304). 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 - Active Ingredient

Active ingredient: Salicylic Acid 1.5% 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 have a known allergy to Salicylic Acid or aspirin.Using other topical acne medications at the same time or right after use of this product may increase drynes or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.

Otc - When Using

When using this product
  • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. If you have aspirin sensitivity, consult a physician prior to use.

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 AcneFree 3-in-1 Acne Night Repair.
  • Moisten skin.
  • Shake can before use.
  • Press down firmly on dispenser and apply a small amount of foam (not more than a dollop the size of golf ball) into hand.
  • Using fingers, apply to face and gently massage to cleanse.
  • Rinse thoroughly with warm water and pat dry.
  • If bothersome peeling occurs, reduce application use.
  • If going outside, use a sunscreen.

Storage And Handling

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

Inactive Ingredient

Inactive ingredients: Avena Sativa (Oat) Kernel Extract, Bisabolol, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Glycerin, Methylisothiazolinone, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Sodium C14-16 Olefin Sulfonate, Tetrasodium Glutamate Diacetate, Water/Aqua/Eau, Zinc PCA, Zingiber Officinale (Ginger) Root Extact.

Package Label.Principal Display Panel

AcneFree SensitiveGentle Formula Acne Pore CleanserSalicylic Acid 1.5%Rinse-Off Foam Medicine Stays In Pores Even After Rinsing

* Please review the disclaimer below.