Acne Defense Daily Treatment Serum
FDA Label NDC 57627-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Merle Norman Cosmetics for the product Acne Defense Daily Treatment Serum (NDC 57627-202). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active (medicinal)                Purpose

Benzoyl Peroxide 2.5%   Acne Treatment   

Otc - Purpose

Uses 

For the treatment of acne

Dries and helps clear up acne pimples and allows skin to heal

helps prevent new acne pimples from forming

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

Indications & Usage

Stop use and ask a doctor if

  • irritation becomes severe

Warnings

Warnings

For external use only

Do not use if

  • have very senstive skin
  • are sensitive to benzoyl peroxide

    • When using this product

    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.

    Avoid unnecessary sun exposure and use a sunscreen

    avoid contact with eyes, lips  and mouth

    avoid contact with hair and dyed fabrics which may be bleached by this product

    Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irriration may be reduced by using the product less frequently or in a lower concentration

Dosage & Administration

Directions

  • Clean the skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer one to three times daily
      • Because excessive drying of the skin may occur, start with one application daily then gradually increase to two or three times daily if needed or directed by a doctor. If bothersome dryness or peeing occurs, reduce application to once a day or every other day
        • If going outside apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

Inactive Ingredient

Inactive (Non-medicinal) Ingredients

Water, Glycerin, Isopropyl Myristate, Pentylene Glycol, Polyacrylamide, C13-14 Isoparrafin, Laureth-7, Disodium EDTA

Package Label.Principal Display Panel

Acne Defense Daily Treatment Serum

Gel

33g

Net Wt. 1.15 Oz

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