PROSKI BENZO- benzoyl peroxide gel

PROSKI BENZO by

Drug Labeling and Warnings

PROSKI BENZO by is a Otc medication manufactured, distributed, or labeled by PHARMAMED USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrous Benzoyl Peroxide 5%

Topical Gel

PURPOSE

Anti Acne

USE

Anti Acne Gel, Used for all stages of common 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

Start treatment with PROSKI BENZO once a day. The evening is the best time or as suggested by a dermatologist.

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 20º-25ºC (68º-77ºF). Do not freeze. Protect from direct sunlight

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

Hydrous Benzoyl Peroxide Gel 5%

Topical Gel

KERATOLYTIC

Net Wt. 20g (0.70oz)

GO/DRUGS/571

INGREDIENTS AND APPEARANCE

PROSKI BENZO 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84289-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
ROSE OIL (UNII: WUB68Y35M7)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84289-216-20	1 in 1 CARTON	04/01/2025
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/01/2025

Labeler - PHARMAMED USA INC (065607328)