Active Ingredient
Benzoyl peroxide 10%
Clarity Clear Skin Solutions Cream
FDA Label NDC 54473-402
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Clarity Clear Skin Solutions (NDC 54473-402). 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 active ingredient, purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Indications & Usage
Uses for the treatment and management of acne
Warnings
For external use only.
Otc - Do Not Use
Do not use if you
- have very sensitive skin
- are sensitive to benzoyl peroxide
Otc - When Using
When using this product
- skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor.
- 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. Irritation may be reduced by using the product less frequently or in lower concentration.
Otc - Stop Use
Stop use and ask a doctor if excessive irritation of the skin develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Dosage & Administration
Directions
- cleanse and tone skin thoroughly before application
- cover the entire affected area with a thin layer 1-3 times daily
- because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce daily 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 and ask a doctor.
- Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Other Information Store at room temperature 68-77°. Protect from freezing.
Inactive Ingredient
Aqua (Water/Eau), Benzoyl Peroxide Gel, Glycerin, Panthenol, Ethyl Macadamiate, Cetyl Alcohol, Stearic Acid, Niacinamide, Polyglyceryl-3 Methyl Glucose Distearate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Steareth-21, Phenoxyethanol, Bisabolol, Polysorbate 60, Steareth-2, Xanthan Gum, Allantoin, Potassium Sorbate, Chlorella Vulgaris Extract.
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