benzoyl peroxide description, usages, side effects, indications, overdosage, supplying and lots more!

benzoyl peroxide

Perrigo New York Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Perrigo Benzoyl Peroxide 10% Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne treatment

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

  • 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

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Benzoyl Peroxide 10%

Aqueous Base, Acne Treatment Gel

Package/Label Principal Display Panel
Benzoyl Peroxide 10% Carton Image 1 Benzoyl Peroxide 10% Carton Image 2

benzoyl peroxide

BENZOYL PEROXIDE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45802-308
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 10 g

Inactive Ingredients

Ingredient Name Strength
DIMETHICONE
DISODIUM LAURYL SULFOSUCCINATE
EDETATE DISODIUM
GLYCERIN
METHYLPARABEN
POLOXAMER 182
water
SILICON DIOXIDE
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 TUBE
2 90 in 1 TUBE
3 NDC:45802-308-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2012-04-06


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