Breakout Clearing Emergency Spot Fix
FDA Label NDC 68479-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermalogica, Inc. for the product Breakout Clearing Emergency Spot Fix (NDC 68479-202). 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 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 (5.0%)

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

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

When Using This Product

  • Apply to affected areas only.
  • Avoid unnecessary sun exposure and use sunscreen.
  • This product may bleach hair or dyed fabrics.
  • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.

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 Emergency Spot Fix to dry, then follow directions of the sunscreen labeling.
  • If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water/Aqua/Eau, PEG-8, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Enantia Chlorantha Bark Extract, Oleanolic Acid, Lavandula Angustifolia (Lavender) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Spiraea Ulmaria Extract, Cetyl Alcohol, Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Polysorbate 80, Glyceryl Stearate, Caprylic/Capric Triglyceride, Ethylhexylglycerin, Butylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Xanthan Gum, Disodium EDTA, Phenoxyethanol.

Questions Or Comments

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

Principal Display Panel - 9 Ml Tube Carton

dermalogica®
clear

5%
benzoyl
peroxide

Breakout Clearing
Emergency
Spot Fix

0.3 US FL OZ / 9 mL e

Principal Display Panel (9 mL Tube Carton)

Principal Display Panel (9 mL Tube Carton)

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