FDA Label for Benzoyl Peroxide
View Indications, Usage & Precautions
Benzoyl Peroxide Product Label
The following document was submitted to the FDA by the labeler of this product Padagis Israel Pharmaceuticals Ltd. 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 medication
Use
for the treatment of acne
Warnings
For external use only
Do Not Use
if you
• have very sensitive skin• are sensitive to benzoyl peroxide
When Using This Product
• 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 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 becomes severe
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
• shake well• 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 below.• wet area to be cleansed• apply acne wash and gently massage area for 1-2 minutes• rinse thoroughly and pat dry• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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
carbomer homopolymer, citric acid*, edetate disodium, glycerin, imidurea, lauryl methacrylate/glycol dimethacrylate crosspolymer, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide *may contain this ingredient
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Benzoyl Peroxide 10%
Acne Medication Wash
NET WT 5 OZ (142 g)
* Please review the disclaimer below.