Active Ingredient:
Benzoyl Peroxide 10%
Benzoyl Peroxide 10% Gel
FDA Label NDC 68723-306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Axia Medical Solutions, Llc for the product Benzoyl Peroxide 10% Gel (NDC 68723-306). 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, uses:, warnings:, do not use if you:, when using the product:, stop use and ask a doctor if:, 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
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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