Breakout Clearing Daytime Treatment
FDA Label NDC 68479-160

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermalogica, Inc. for the product Breakout Clearing Daytime Treatment (NDC 68479-160). 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 other, active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a physician, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Benzoyl Peroxide (2.5%).

Purpose

Acne Treatment.

Use

  • for the treatment of acne

Warnings

For external use only

Do Not Use

  • in or near eyes
  • on broken skin
  • on lips or large areas of the body
  • if you have very sensitive skin
  • if you are sensitive to benzoyl peroxide

When Using This Product

  • apply to affected areas only
  • avoid unnecessary sun exposure and use sunscreen
  • This product may bleach hair or dyed fabrics.
  • Using other topical acne products at the same time or immediately following the use of this product may increase dryness or irritation of the skin. Only one product should be used unless directed by a physican.

Stop Use And Ask A Physician

  • if too much skin irritation or sensitivity develops or increases

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.

Directions

  • Cleanse the skin thoroughly before applying.
  • Cover the affected area with a thin layer 1 to 3 times a day.
  • Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside use a sunscreen. Allow Daytime Treatment to dry then follow directions of the sunscreen labeling.

Inactive Ingredients

Water/Aqua/Eau, Niacinamide, Glycerin, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Boerhavia Diffusa Root Extract, Sodium Acrylates Copolymer, Lecithin, Galactoarabinan, Glyceryl Polyacrylate, Polyisobutene, Dipotassium Glycyrrhizate, Butylene Glycol, Xanthan Gum, Polyacrylate-13, 1,2-Hexanediol, Polysorbate 20, Disodium EDTA, Citric Acid, Ethylhexylglycerin, Phenoxyethanol.

Other Information

  • Protect this product from excessive heat and direct sun.

Questions Or Comments

Call toll free 1-800-831-5150 in the US

Principal Display Panel - 60 Ml Tube Carton

dermalogica®
clear

2.5%
benzoyl
peroxide

Breakout Clearing
Daytime
Treatment

2.0 US Fl. Oz. / 60 mL e

Principal Display Panel (60 mL Tube Carton)

Principal Display Panel (60 mL Tube Carton)

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