OC8- benzoyl peroxide gel
Ferndale Laboratories, 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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OC8 Adult Acne Treatment Gel 7% Benzoyl Peroxide

Active Ingredient

Benzoyl peroxide 7%

Purpose

Acne Treatment

Uses

for the treatment of acne
penetrates pores to eliminate most acne pimples
helps prevent new acne pimples from forming

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 the 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 OC8 Adult Acne Treatment 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 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

purified water, DVB/isobornyl methacrylate/lauryl methacrylate copolymer, propylene glycol, PEG-400, carbomer homopolymer, sodium hydroxide, edetate disodium

Questions?

1-866-668-7482 weekdays

Package Display

OC8
Adult Acne Treatment Gel
7% Benzoyl Peroxide
Net Wt. 1.6 oz. (45 g)
Manufactured for
Ferndale Healthcare Inc.
By Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A.
Toll Free (888) 548-0900
www.ferndalehealthcare.com
OC Eight and OC8 are registered trademarks of Ferndale IP, Inc.
NDC 0496-0973-45
OC8 Carton

OC8Carton

OC8
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0496-0973
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)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0496-0973-45	45 g in 1 TUBE; Type 0: Not a Combination Product	08/13/2012	09/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	08/13/2012	09/30/2019

Labeler - Ferndale Laboratories, Inc. (005320536)

Name	Address	ID/FEI	Business Operations
Establishment
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0973)

Revised: 10/2019

Document Id: 94677172-e646-1679-e053-2a95a90a3f25

Set id: 9d84b8f4-432b-44fa-9c4d-362615454fe6

Version: 4

Effective Time: 20191008

Ferndale Laboratories, Inc.