HYDROUS BENZOYL PEROXIDE 5% TOPICAL GEL

Manufacturer
PHARMAMED USA INC
Effective date
2026-05-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
weekly-update
Hydrated at
2026-06-03 18:02:30

Label at a glance#

ProductPROSKI BENZO
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

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...

Storage and handling

Storage: store in a cool dry place at 20º-25ºC (68º-77ºF). Do not freeze. Protect from direct sunlight

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydrous Benzoyl Peroxide 5%

Topical Gel

PURPOSE

OTC - PURPOSE SECTION

Anti Acne

USE

INDICATIONS & USAGE SECTION

Anti Acne Gel, Used for all stages of common Acne

WARNING

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • irritation becomes severe

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 AND HANDLING SECTION

Storage: store in a cool dry place at 20º-25ºC (68º-77ºF). Do not freeze. Protect from direct sunlight

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

methylparaben, polysorbate 80, sodium hydroxide, purified water, carbomer homopolymer

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

(754) 200-8994 (Mon-Fri 8 AM to 4 PM EST)

Recent Major Changes (§ 201.57(a)(5)) - Rev 05-01-2026

RECENT MAJOR CHANGES SECTION

• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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

Outer Label ImageOuter Label Image

Inner Label ImageInner Label Image

Pinted InsertPinted Insert

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84289-21684289-216-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5259d7b2-f79c-788a-e063-6294a90a14482c75b3b9-6321-dede-e063-6394a90a58802026-05-21WarningsExact identifier
spl set id: 2c75b3b9-6321-dede-e063-6394a90a5880

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.