DailyMed - PROSKI BENZO- benzoyl peroxide gel

NDC Code(s): 84289-216-20
Packager: PHARMAMED USA INC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 18, 2025

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ACTIVE INGREDIENT
Benzoyl peroxide 5%

Benzoyl peroxide 5%
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PURPOSE
Acne treatment

Acne treatment
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USE
For the treatment of acne

For the treatment of acne
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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 ...
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)

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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 ...

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.
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OTHER INFORMATION
Storage: store in a cool dry place at 20º-25ºC (68º-77ºF). Do not freeze

Storage: store in a cool dry place at 20º-25ºC (68º-77ºF). Do not freeze
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INACTIVE INGREDIENTS
methylparaben, polysorbate 80, sodium hydroxide, purified water, carbomer homopolymer

methylparaben, polysorbate 80, sodium hydroxide, purified water, carbomer homopolymer
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QUESTIONS OR COMMENTS?
(754) 200-8994 (Mon-Fri 8 AM to 4 PM EST)

(754) 200-8994 (Mon-Fri 8 AM to 4 PM EST)
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 84289-216-20 - Benzoyl Peroxide Gel BP - Net Wt. 20g - GOA/DRUGS/571

NDC 84289-216-20

Benzoyl Peroxide Gel BP

Net Wt. 20g

GOA/DRUGS/571

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Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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Safety

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Label: PROSKI BENZO- benzoyl peroxide gel

View Package Photos

Drug Label Info

Safety

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Drug Label Information

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

PROSKI BENZO- benzoyl peroxide gel

Number of versions: 1

PROSKI BENZO- benzoyl peroxide gel

PROSKI BENZO- benzoyl peroxide gel

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PROSKI BENZO- benzoyl peroxide gel

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.