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OC Eight

Biopelle, Inc.

OC Eight Acne Mattifying Gel


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Benzoyl peroxide 7%

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, use only 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 possible 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.

Directions

  • cleanse the skin thoroughly before applying
  • cover the entire affected area with a thin layer 1 to 3 times a day
  • because excessive drying of th skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 a sunscreen after using this product.  Allow OC Eight Acne Mattifying Gel to dry, then 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 59° - 86° F (15° - 30° C).

Inactive Ingredients

water, DVB/isobornyl methacrylate/lauryl methacrylate copolymer, propylene glycol, PEG-400, carbomer 940, sodium hydroxide, disodium EDTA

Questions?

1-866-424-6735 weekdays

Package Display














OC Eight

OC Eight

benzoyl peroxide GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42485-003
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 7 mg

Inactive Ingredients

Ingredient Name Strength
water
propylene glycol
CARBOMER HOMOPOLYMER TYPE C
SODIUM HYDROXIDE
EDETATE DISODIUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42485-003-01 45 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-04-01


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