FDA Label for Benzefoam
View Indications, Usage & Precautions
Benzefoam Product Label
The following document was submitted to the FDA by the labeler of this product Bausch Health Us, 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 (5.3%)
Purpose
Acne Treatment
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 are 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.▪ do not puncture or incinerate container. Contents under pressure.▪ do not expose to temperatures above 120°F (49°C).
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.
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 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▪ can be used as either a leave-on or short contact application
Other Information
■ store at room temperature 15°-25°C (59°-77°F). Protect from freezing. Store upright.
Inactive Ingredients
BHT, C12-15 alkyl benzoate, cetearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, hydrofluorocarbon 134a, methylparaben, propylene glycol, propylparaben, purified water,
sodium citrate, steareth-10
Questions/Comments?
Call: 1-800-321-4576
Package/Label Principal Display Panel - Carton
NDC: 0187-0194-10
BenzEFoam
Emollient Foam
benzoyl peroxide 5.3%
Acne Treatment
Emollient Foam
For Topical Use Only
Do Not Use in Eyes
Will not dispense entire contents.
Container is overfilled to guarantee
dispensing a minimum of 100 grams.
Back Applicator Included
Ortho Dermatologics
Net Wt 3.5 OZ (100 g)
* Please review the disclaimer below.