Oil-free Acne Cleanser
FDA Label NDC 50544-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by University Medical Pharmaceuticals Corp for the product Oil-free Acne Cleanser (NDC 50544-001). 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 - 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 every morning and evening. Apply a dime-size amount to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome peeling occurs, reduce application use. May also be used on chest or back.

Inactive Ingredient

Inactive ingredients: Water, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Glycerin, Cocamidopropyl Betaine, Bakuchiol, Panthenyl Triacetate, Bisabolol, Benzalkonium Chloride, Chamomilla Recuita (Matricaria) Flower Extract, Naringenin, Sea Whip Extract, Polyethylene, Xanthan Gum, Cetyl Alcohol, Magnesium Aluminum Silicate, Sodium Benzoate, Caprylic/Capric Triglyeride, Farnesol, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone.

Package Label.Principal Display Panel

AcneFree Clear Skin TreatmentsOil-Free Acne CleanserGentle Exfoliating MicrobeadsAdvanced Micro-Benzoyl Peroxide

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