OC EIGHT - benzoyl peroxide gel 
Biopelle, Inc.

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.

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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

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®
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.

Carton
OC EIGHT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42485-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE7 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture

Revised: 7/2011
Document Id: d95c940a-8f82-4928-8512-188b9f9224f0
Set id: 018288db-8278-4e5d-8749-4745c64663a9
Version: 1
Effective Time: 20110711
 
Biopelle, Inc.