Breakout Clearing Overnight Treatment
FDA Label NDC 68479-313

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 Overnight Treatment (NDC 68479-313). 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, otc - purpose, warnings, do not use, when using this product, otc - keep out of reach of children, directions, 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

Salicylic Acid (2.0%).

Otc - Purpose

  • for the treatment of acne

Warnings

For external use only.

Do Not Use

  • in or near eyes. If contact occurs, flush thoroughly with water

When Using This Product

  • apply to affected areas only
  • 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.

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

  • Clean the skin thoroughly before applying.
  • Cover the affected area with a thin layer at night.
  • Because too much drying of the skin may occur, start with 1 application daily at night, and if bothersome dryness or peeling occurs, reduce application to 2 to 3 times per week.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, Isohexadecane, PEG-32, Glyceryl Stearate, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Stearic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Spiraea Ulmaria Extract, Camphor, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra Rhizome/Root, Porphyra Umbilicalis Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sodium Hyaluronate Crosspolymer, Caprylic/ Capric Triglyceride, Zinc Acetate, Potassium Jojobate, Propanediol, PVM/ MA Copolymer, Ceteareth-20, Xanthan Gum, Polysorbate 60, Jojoba Alcohol, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions Or Comments

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

Principal Display Panel - 59 Ml Tube Carton

dermalogica®
clear

2%
salicylic
acid

Breakout Clearing
Overnight
Treatment

2.0 US FL OZ / 59 mL e

Principal Display Panel (59 mL Tube Carton)

Principal Display Panel (59 mL Tube Carton)

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