Benzoyl Peroxide description, usages, side effects, indications, overdosage, supplying and lots more!

Benzoyl Peroxide

CINTEX SERVICES, LLC

  • 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
BP Foam 5.3%

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Benzoyl peroxide 5.3%

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.
  • do not puncture or incinerate; contents under pressure

Stop use and ask a doctor if irritation becomes severe.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer and rinse thoroughly 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°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

Inactive ingredients

emulsifying wax, methylparaben, propylparaben, purified water, tetrafluoroethane

Questions?

1-855-899-4237

Benzoyl Peroxide

BENZOYL PEROXIDE AEROSOL, FOAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:24470-912
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 53 mg

Inactive Ingredients

Ingredient Name Strength
CETOSTEARYL ALCOHOL
POLYSORBATE 20
METHYLPARABEN
PROPYLPARABEN
water
1,1,2,2-TETRAFLUOROETHANE

Product Characteristics

Color
white

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24470-912-60 60 in 1 CANISTER
2 NDC:24470-912-10 100 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-03-04


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Be sure to consult your doctor before taking any medication!
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