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

Benzoyl Peroxide

Harris Pharmaceutical, 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
BENZOYL PEROXIDE TOPICAL CLEANSER 6%

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active Ingredient

6% 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.

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 - 170.3 g Bottle Label

NDC 67405-835-06

BENZOYL
PEROXIDE
TOPICAL
CLEANSER
6%

FOR TOPICAL USE

Net Weight 6 oz
(170.3 g)

HARRIS

PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label

Benzoyl Peroxide

Benzoyl Peroxide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67405-835
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 60 mg

Inactive Ingredients

Ingredient Name Strength
CETYL ALCOHOL
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE
EDETATE DISODIUM
GLYCERIN
LAURETH-12
magnesium aluminum silicate
propylene glycol
water
SODIUM COCO-SULFATE
SODIUM LAUROAMPHOACETATE
XANTHAN GUM

Product Characteristics

Color
WHITE (viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67405-835-06 178 in 1 BOTTLE
2 NDC:67405-835-12 355 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-11-18


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Be sure to consult your doctor before taking any medication!
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