FDA Label for Benzoyl Peroxide 10% Gel
View Indications, Usage & Precautions
Benzoyl Peroxide 10% Gel Product Label
The following document was submitted to the FDA by the labeler of this product Axia Medical Solutions, Llc. 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.
Active Ingredient:
Benzoyl Peroxide 10%
Purpose
Acne Treatment
Uses:
For the treatment of acne.
Warnings:
For external use only.
Do Not Use If You:
• Have sensitive skin. • Are sensitive to benzoyl peroxide.
When Using The Product:
• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If this occurs only use one topical acne medication at a time • Avoid unnecessary sun exposure and use a sunscreen • Avoid contact with the 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 a lower concentration.
Stop Use And Ask A Doctor If:
Irritation become severe.
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 this product • Cover the entire affected area with a thin layer one to three times daily • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor • If bothersome dryness or peeling occurs, reduce 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 of both products and ask a doctor.
Inactive Ingredients:
Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Panthenol, PEG-8, PEG-14 Palmeth-60 Hexyl Dicarbamate, Sodium Hyaluronate, Triethanolamine, and Water.
Other Information:
• Store at controlled room temperature 15-30°C (59-86°F)
Questions?:
866-494-4466, Mon-Fri 8:00AM-5:00PM
Dist. By Axia Medical Solutions, 2105 Camino Vida Roble, Carlsbad, Ca. 92011
www.dermesse.com 866-494-4466 office, 760-931-8267 fax
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