BENZOYL PEROXIDE CREAMY WASH  - benzoyl peroxide cream 
BENZOYL PEROXIDE ACNE WASH KIT  - benzoyl peroxide cream 
Hi Tech Pharmacal Co Inc

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Benzoyl Peroxide 4% Creamy Wash and Benzoyl Peroxide 8% Creamy Wash are topical preparations containing benzoyl peroxide as the active
ingredient. Benzoyl Peroxide 4% Creamy Wash and Benzoyl Peroxide 8% Creamy Wash contain: 4% and B% Benzoyl Peroxide, respectively, in a
lathering cream vehicle containing Benzyl Alcohol, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Disodium EDTA, Disodium Oleamido
MEA-Sulfosuccinate, Glycerin, Laureth-12, Magnesium Aluminum Silicate, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Lauryl Sulfoacetate,
Sodium Octoxynol-2 Ethane Sulfonate, Sodium PCA, Xanthan Gum.

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.

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

Benzoyl Peroxide 4% Creamy Wash and Benzoyl Peroxide B% Creamy Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product

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 lindings is not known.

Pregnancy: Category C - Animal reproduction studies have not been conducted with benzoyl peroxide. II 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 - II 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.

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.

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% Creamy Wash or Benzoyl Peroxide 8% Creamy Wash, 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.

Benzoyl Peroxide 4% Creamy Wash is supplied in 170.1g (6.0 oz) tubes.
Benzoyl Peroxide 8% Creamy Wash is supplied in 170.1g (6.0 oz) tubes.
Store at controlled room temperature. 15°-30°C (59°-86°F) .

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BENZOYL PEROXIDE CREAMY WASH  benzoyl peroxide creamy wash   cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-390 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 4 g  in 100 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-390-06 12 CARTON In 1 CASE contains a CARTON 1 1 TUBE In 1 CARTON This package is contained within the CASE (50383-390-06) and contains a TUBE 1 170.1 g In 1 TUBE This package is contained within a CARTON and a CASE (50383-390-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/01/2008

BENZOYL PEROXIDE ACNE WASH KIT  benzoyl peroxide acne wash kit   cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-392 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 4 g  in 100 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-392-06 27 TUBE In 1 CASE contains a TUBE 1 170.1 g In 1 TUBE This package is contained within the CASE (50383-392-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/01/2008

Labeler - Hi Tech Pharmacal Co Inc (101196749)

Registrant - Harmony Labs, Inc. (105803274)

Establishment
Name	Address	ID/FEI	Operations
Harmony Labs, Inc.		105803274	manufacture, label, pack, relabel, repack

Revised: 05/2010Hi Tech Pharmacal Co Inc