BENZOYL PEROXIDE description, usages, side effects, indications, overdosage, supplying and lots more!

BENZOYL PEROXIDE

TriMarc Labs
TriMarc Labs

  • 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 GEL 10% DRUG FACTS



FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient

10% benzoyl peroxide

Uses

Use

  • treat acne
  • dries up acne pimples
  • helps prevent new acne pimples

Warnings

For external use only

Do not use

  • on broken skin
  • in or near the eyes
  • on large areas of the body
  • if you have very sensitive skin
  • if you are sensitive to benzoyl peroxide

Stop use and ask a doctor

if skin irritation increases or sensitivity develops

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions


  • Cleanse skin thoroughly before applying
  • cover entire affected area with a thin layer 1 to 3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside use sunscreen.
  • Allow Benzoyl Peroxide to dry, then follow directions in the sunscreen labeling.

Other Information

  • store at room temperature 15°-30°C (59°-86°F)
  • Lot No. & Exp. Date: see box or see bottle label
  • Avoid excessive heat
  • Keep tightly closed

Purpose

Purpose

Acne Treatment

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • apply to affected areas only
  • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
  • you might experience increased skin dryness or irritation (redness, burning, itching,peeling, or swelling)
  • do not use other topical acne medications at the same time or right after, as this may increase dryness or irritation of the skin. Use only one drug unless directed by a doctor.
Inactive Ingredients







Manufactured for:
TriMarc Laboratories
Oklahoma City, OK 73127
A Division of PD-Rx Pharmaceuticals, Inc.



PRINCIPAL DISPLAY PANEL 2OZ BOTTLE LABEL

NDC 68752-210-60

BENZOYL PEROXIDE
TOPICAL GEL
10%

FOR TOPICAL USE

Net Weight 2oz

TRIMARC






BENZOYL PEROXIDE

BENZOYL PEROXIDE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68752-210
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 100 mg

Inactive Ingredients

Ingredient Name Strength
water
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
GLYCERIN
propylene glycol
DMDM HYDANTOIN
PHENOXYETHANOL
BUTYLPARABEN
ETHYLPARABEN
LAVENDER OIL
SODIUM HYDROXIDE
METHYLPARABEN
PROPYLPARABEN

Product Characteristics

Color
white

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68752-210-60 60 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2004-11-16


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Be sure to consult your doctor before taking any medication!
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