Benzoyl Peroxide

Harris Pharmaceutical, Inc.

BENZOYL PEROXIDE TOPICAL WASH 10%

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient
• Purpose
• Use
• Warnings
  • Do not use if you
  • When using this product
  • Keep out of reach of children
• Directions
• Benzoyl Peroxide Other information
• Inactive Ingredients
• PRINCIPAL DISPLAY PANEL - 148 g Bottle Label

FULL PRESCRIBING INFORMATION

DRUG FACTS

Active Ingredient

10% benzoyl peroxide USP

Purpose

Acne medication

Use

• For the treatment of acne

Warnings

For external use only.

• Avoid contact with eyes, eyelids, lips and mucous membranes.

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product

• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with eyes, lips, and mouth.
• Avoid contact with hair or 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.
• 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.

• 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

SHAKE WELL.

• Clean the skin thoroughly before applying this product.
• One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
• 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.
• Follow directions in the sunscreen labeling.
• If irritation or sensitivity develops stop use of both products and ask a doctor.

Benzoyl Peroxide Other information

Store at controlled room temperature, 15° - 25°C (59° - 77°F)

Inactive Ingredients

Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

Manufactured for:
Harris Pharmaceutical, Inc.,
Fort Myers, Florida 33908
Manufactured by:
Groupe Parima
Montreal, QC
H4S 1X6 CANADA Rev 06/11

PRINCIPAL DISPLAY PANEL - 148 g Bottle Label

NDC 67405-830-05

BENZOYL
PEROXIDE
TOPICAL
WASH 10%

FOR TOPICAL USE

Net Weight 5 oz
(148 g)

HARRIS