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benzoyl peroxide

Perrigo New York Inc

Perrigo Benzoyl Peroxide 5% Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Benzoyl peroxide 5%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

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.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • •shake well
  • •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.
  • •wet area to be cleansed
  • •apply acne wash and gently massage area for 1-2 minutes
  • •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. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

carbomer homopolymer, citric acid*, edetate disodium, glycerin, imidurea, lauryl methacrylate/glycol dimethacrylate crosspolymer, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide *may contain this ingredient

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Benzoyl Peroxide 5%

Acne Medication Wash

benzoyl peroxide

BENZOYL PEROXIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45802-280
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 5 g

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERIN
IMIDUREA
water
SODIUM C14-16 OLEFIN SULFONATE
SODIUM HYDROXIDE
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45802-280-01 142 in 1 BOTTLE
2 NDC:45802-280-34 227 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2013-01-24


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Be sure to consult your doctor before taking any medication!
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