Oc Eight (Benzoyl Peroxide) Gel [Biopelle, Inc.] -

OC EIGHT (BENZOYL PEROXIDE) GEL [BIOPELLE, INC.]
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NDC	42485-003-01
Set ID	018288db-8278-4e5d-8749-4745c64663a9
Category	HUMAN OTC DRUG LABEL
Packager	Biopelle, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333D

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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®
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.

INGREDIENTS AND APPEARANCE

OC EIGHT
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42485-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	7 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333D	04/01/2011

Labeler - Biopelle, Inc. (808158823)

Name	Address	ID/FEI	Business Operations
Establishment
Ferndale Laboratories, Inc.		005320536	manufacture

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Medic

OC EIGHT (BENZOYL PEROXIDE) GEL [BIOPELLE, INC.]

Do not use if you

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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