Active Ingredient

Benzoyl peroxide 7%

Purpose

Acne Treatment

for the treatment of acne

For external use only.

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.

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

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.

Store at controlled room temperature 59° - 86° F (15° - 30° C).

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

1-866-424-6735 weekdays

LET ME BE PERFECTLY CLEAR Acne Treatment Kit NDC 42485-004-01

AFA Cream Cleanser with Dead Sea Minerals 8 fl oz / 236 mL

PRESCRIBEDsolutions Line Subtractor 27 mL / .9 fl oz

OC Eight® Acne Mattifying Gel 1.6 oz / 45 g

Marketed by Biopelle, Inc.
A Ferndale Pharma Group company
Ferndale, Michigan 48220
www.biopelle.com

LetMeBePerfectlyClearCartonFront

LET ME BE PERFECTLY CLEAR
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42485-004

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42485-004-01	1 in 1 CARTON

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	45 g

Part 1 of 1

OC EIGHT
benzoyl peroxide gel

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

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