Active Ingredient
Benzoyl peroxide 5%
Proski Benzo
FDA Label NDC 84289-216
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmamed Usa Inc for the product Proski Benzo (NDC 84289-216). 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, use, warning, do not use, when using this 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
Use
For the treatment of acne
Warning
To be sold by retail on the prescription of a Registered Medical Practitioner only
DO NOT ACCEPT IF TAGGER IS BROKEN. USE THE BUILT-IN PIN ON THE CAP TO PIERCE THE TAGGER
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
Avoid contact with eyes and mouth.
Keep the tube tightly closed after use.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
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.
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.
Other Information
Storage: store in a cool dry place at 20°-25°C (68°-77°F). Do not freeze
Inactive Ingredients
methylparaben, polysorbate 80, sodium hydroxide, purified water, carbomer homopolymer
Questions Or Comments?
(754) 200-8994 (Mon-Fri 8 AM to 4 PM EST)
Package/Label Principal Display Panel
NDC 84289-216-20
Benzoyl Peroxide Gel BP
Net Wt. 20g
GOA/DRUGS/571
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