OC Eight

Dosage form: gel
Ingredients: BENZOYL PEROXIDE 7mg in 1g
Labeler: Biopelle, Inc.
NDC Code: 42485-003

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

OC Eight Acne Mattifying Gel

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 DisplayOC Eight®
Acne Mattifying Gel
Net Wt. 1.6 oz. (45 g)
NDC 42485-003-01

Distributed by Biopelle, Inc.
a Ferndale Pharma Group company
Ferndale, Michigan 48220
866-424-6735
www.biopelle.com

OC Eight® and OC8® are registered trademarks of Ferndale IP, Inc.

OC EIGHT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42485-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE7 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE C 
SODIUM HYDROXIDE 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:42485-003-0145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D04/01/2011
Labeler - Biopelle, Inc. (808158823)
Establishment
NameAddressID/FEIOperations
Ferndale Laboratories, Inc.005320536manufacture

Revised: 07/2011
 
Biopelle, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)