Clinac BPO 7 (Benzoyl Peroxide Gel USP, 7%) Acne Control Gel

CLINAC BPO 7  - benzoyl peroxide gel 
Ferndale Laboratories, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DESCRIPTION

Clinac® BPO 7 (benzoyl peroxide) is a topical preparation containing 7% benzoyl peroxide as the active ingredient in a gel vehicle containing purified water, propylene glycol, Acrysorb® (brand of acrylates copolymer), PEG-400, carbomer 940, disodium EDTA, and sodium hydroxide.

The chemical structure for the active ingredient is:

BenxoylPeroxide

benzoyl peroxide

C14H10O4 (anhydrous) 242.23

CLINICAL PHARMACOLOGY

The exact method of action of benzoyl peroxide in acne vulgaris is not known.  Benzoyl Peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes.  This action combines with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.

Little is known about the percutaneous penetration, metabolism and excretion of benzoyl peroxide.  Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.  There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.

INDICATIONS AND USAGE

Clinac® BPO 7 is indicated for the topical treatment of mild to moderate acne vulgaris.

CONTRAINDICATIONS

Clinac® BPO 7 should not be used in patients who have shown hypersensitivity to benzoyl peroxide or any of the other ingredients in this product.

WARNINGS

FOR EXTERNAL USE ONLY.  KEEP OUT OF REACH OF CHILDREN.  Avoid contact with eyes, eyelids, lips and mucous membranes.  If inadvertent contact occurs, rinse area thoroughly with water.  Contact with colored material, including fabric and hair, may result in discoloration.  When using Clinac® BPO 7, avoid unnecessary sun exposure and use a sunscreen.  In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

PRECAUTIONS


Information for Patients

  • Avoid contact with eyes, eyelids, lips and mucous membranes.
  • May discolor hair and fabrics.
  • Avoid unnecessary sun exposure and use a sunscreen.
  • Use of oil-free make-up recommended.
  • If severe irritation develops, discontinue use and consult your physician.


Carcinogenesis, Mutagenesis and Impairment of Fertility

Studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide act as a tumor promoter.  The clinical significance of these finding to humans is not known.  Benzoyl peroxide has not been found to be mutagenic (Ames test) and there are no published data indicating that it impairs fertility.

Pregnancy: Category C

Animal reproductive studies have not been conducted with benzoyl peroxide.  It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Benzoyl peroxide should be used by a pregnant woman only if clearly needed.  There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.

Nursing Mothers

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 have not been established.

ADVERSE REACTIONS

Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.  If excessive scaling, erythema or edema occurs, the use of Clinac® BPO 7 should be discontinued and appropriate therapy instituted.  To hasten resolution of adverse effects, cool compresses may be used.  After reaction clears, a reduced dosage schedule may often be resumed if the reaction is judged not to be due to allergenicity.

DOSAGE AND ADMINISTRATION

Wash and dry hands, face and affected areas with a gentle cleanser before application.  Apply a thin layer of Clinac® BPO 7 to the affected area once or twice daily, or as directed by your physician.  Replace cap tightly after use.

HOW SUPPLIED

Clinac® BPO 7  Gel    45 gram tube    NDC 0496-0857-45

Store at 25°C (77°F); excusions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature.].

Rx Only.

Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A
Toll free (888) 548-0900
www.ferndalelabs.com

Protected under U.S. Patent.
Clinac® and Acrysorb® are registered trademarks of Dow Pharmaceutical Sciences Corp.

Package Label

ClinacBPOCarton


CLINAC BPO 7 
benzoyl peroxide gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0496-0857
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE70 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
POLYETHYLENE GLYCOLS 
CARBOMER HOMOPOLYMER TYPE C 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0496-0857-4545 g in 1 TUBENone
2NDC:0496-0857-9090 g in 1 TUBENone
3NDC:0496-0857-971 g in 1 POUCHNone
4NDC:0496-0857-984 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/12/200011/30/2012

Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIOperations
Ferndale Laboratories, Inc.005320536manufacture

Revised: 03/2012 Ferndale Laboratories, Inc.