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Name:Benzoyl Peroxide
Manufacturer:Kylemore Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


4% and 8% Benzoyl Peroxide Cleansing Lotions

BENZOYL PEROXIDE  - benzoyl peroxide lotion 
Kylemore Pharmaceuticals, LLC

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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4% and 8% Benzoyl Peroxide Cleansing Lotions

DESCRIPTION:

4% and 8% Benzoyl Peroxide Cleansing Lotions are a topical preparation containing benzoyl peroxide as the active ingredient. 4% and 8% Benzoyl Peroxide Cleansing Lotions contain benzoyl peroxide 4% and 8%, respectively, in a lathering vehicle.

Active Ingredient: Benzoyl peroxide 4% (containing dibenzoyl peroxide, water, and modifiers).
Inactive Ingredients: Benzyl Alcohol NF, Cetyl Alcohol, Citric Acid Anhydrous USP, Polyacrylamide/C13-14 Isoparaffin/ Laureth-7, Purified Water, Sodium Lauryl Sulfate, and Sodium Lauryl Sulfoacetate.

Active Ingredient: Benzoyl peroxide 8% (containing dibenzoyl peroxide, water, and modifiers).
Inactive Ingredients: Benzyl Alcohol NF, Cetyl Alcohol, Citric Acid Anhydrous USP, Polyacrylamide/C13-14 Isoparaffin/Laureth-7, Purified Water, Sodium Lauryl Sulfate, and Sodium Lauryl Sulfoacetate.

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, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne. Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

INDICATIONS AND USAGE:

4% and 8% Benzoyl Peroxide Cleansing Lotions are indicated for use in the topical treatment of mild to moderate acne vulgaris. 4% and 8% Benzoyl Peroxide Cleansing Lotions may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.

CONTRAINDICATIONS:

4% and 8% Benzoyl Peroxide Cleansing Lotions should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.

PRECAUTIONS:

General: For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.

Pregnancy:
Category C- Animal reproduction 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.

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:

Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.

DOSAGE AND ADMINISTRATION:

Shake well before using. Wash the affected areas once a day during the first week, and twice a day thereafter as tolerated. Wet skin areas to be treated; apply Benzoyl Peroxide 4% or 8% Cleansing Lotion, work to a full lather, rinse thoroughly and pat dry. Frequency of use should be adjusted to obtain the desired clinical response. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

HOW SUPPLIED:

4% Benzoyl Peroxide Cleansing Lotion is supplied in 10.5 oz. (297 g) plastic bottles, NDC 49769-285-11
8% Benzoyl Peroxide Cleansing Lotion is supplied in 10.5 oz. (297 g) plastic bottles, NDC 49769-286-11.

Store at controlled room temperature, 20°-25° C (68°-77° F).

KEEP THIS AND ALL MEDICTIONS OUT OF THE REACH OF CHILDREN.


Manufactured for:
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Rev. 02/10 285/286-10
P0566

PACKAGING:

Below represents the current packaging being used:

285-11 Label:

label1

286-11 Label:

label2


BENZOYL PEROXIDE 
benzoyl peroxide lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49769-285
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CETYL ALCOHOL  
ANHYDROUS CITRIC ACID  
C13-14 ISOPARAFFIN  
WATER  
SODIUM LAURYL SULFATE  
SODIUM LAURYL SULFOACETATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49769-285-11 297 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2010 10/31/2012

BENZOYL PEROXIDE 
benzoyl peroxide lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49769-286
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 80 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CETYL ALCOHOL  
ANHYDROUS CITRIC ACID  
C13-14 ISOPARAFFIN  
WATER  
SODIUM LAURYL SULFATE  
SODIUM LAURYL SULFOACETATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49769-286-11 297 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2010 03/16/2011

Labeler - Kylemore Pharmaceuticals, LLC (831892471)

Revised: 03/2011 Kylemore Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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