Otc - Active Ingredient
10 percent Benzoyl Peroxide
The following Structured Product Label (SPL) was submitted to the FDA by Acnefree, Llc for the product Benzoyl Peroxide Deep Cleansing Foaming Wash (NDC 80861-112). 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 otc - active ingredient, purpose, use, warnings, do not use if you, when using this product, stop use and sk a doctor if skin irritation becomes severe. keep out of reach of children., keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
10 percent Benzoyl Peroxide
Acne Treatment
for the treatment of acne
For external use only
have very sensitive skin are sensitive to benzoyl peroxide
• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
• avoid unnecessary sun exposure and use sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by using 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.
If swallowed, get medical help or contact a Poison Control Center right away
Keep out of Reach of children
use every morning and evening
• apply a dime-size amount to damp skin and gently massage, avoiding the eye area
• rinse well
• use wash on entire affected area one to two times daily
• because excessive drying of the skin may occur, start with washing one daily, then gradually increase to two times daily as needed, or directed by a doctor
• if bothersome dryness or peeling occurs, reduce cleansing 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.
• may be used on chest or back
Water (Aqua), Glycerin, Propylene Glycol, Cocamidopropyl Hydroxysultaine, Decyl Glucoside, Sodium C14-16 Oleon Sulfonate, Xanthan Gum, Citric Acid, Potassium Hydroxide, Sodium Hyaluronate, Niacinamide, Sodium Sulfate, Avena Sativa (Oat) Kernel Extract, Sodium Lauroyl Lactylate, Glycolic Acid, Phenoxyethanol, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Carbomer, Ceramide EOP
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Correcting the name of the Section Type from Route of Administration to Dosage and Administration
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