FDA Label for Breakout Clearing Emergency Spot Fix
View Indications, Usage & Precautions
Breakout Clearing Emergency Spot Fix Product Label
The following document was submitted to the FDA by the labeler of this product Dermalogica, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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