Stadmed Ethacid

Stadmed Ethacid may be available in the countries listed below.

Ingredient matches for Stadmed Ethacid

Etamsylate

Etamsylate is reported as an ingredient of Stadmed Ethacid in the following countries:

• India

International Drug Name Search

Lynestrénol

Lynestrénol may be available in the countries listed below.

Ingredient matches for Lynestrénol

Lynestrenol

Lynestrénol (DCF) is also known as Lynestrenol (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Losartan / Hydrochlorothiazide Mylan

Losartan/Hydrochlorothiazide Mylan may be available in the countries listed below.

Ingredient matches for Losartan/Hydrochlorothiazide Mylan

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Losartan/Hydrochlorothiazide Mylan in the following countries:

• France

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan/Hydrochlorothiazide Mylan in the following countries:

• France

International Drug Name Search

Amavita Bisacodyl

Amavita Bisacodyl may be available in the countries listed below.

Ingredient matches for Amavita Bisacodyl

Bisacodyl

Bisacodyl is reported as an ingredient of Amavita Bisacodyl in the following countries:

• Switzerland

International Drug Name Search

Staphylex

Staphylex may be available in the countries listed below.

Ingredient matches for Staphylex

Flucloxacillin

Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Staphylex in the following countries:

• Australia


• Germany

International Drug Name Search

Lactat-oral Fresenius

Lactat-oral Fresenius may be available in the countries listed below.

Ingredient matches for Lactat-oral Fresenius

Lactic Acid

Lactic Acid sodium (a derivative of Lactic Acid) is reported as an ingredient of Lactat-oral Fresenius in the following countries:

• Austria

International Drug Name Search

Benzoyl Peroxide Lotion

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:

286-11 Label:

BENZOYL PEROXIDE  benzoyl peroxide  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 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: 03/2011Kylemore Pharmaceuticals, LLC

More Benzoyl Peroxide Lotion resources

• Benzoyl Peroxide Lotion Side Effects (in more detail)
• Benzoyl Peroxide Lotion Use in Pregnancy & Breastfeeding
• Benzoyl Peroxide Lotion Drug Interactions
• Benzoyl Peroxide Lotion Support Group
• 15 Reviews for Benzoyl Peroxide - Add your own review/rating

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Clotrikad

Clotrikad may be available in the countries listed below.

Ingredient matches for Clotrikad

Clotrimazole

Clotrimazole is reported as an ingredient of Clotrikad in the following countries:

• Germany

International Drug Name Search

Glibenclamida

Glibenclamida may be available in the countries listed below.

Ingredient matches for Glibenclamida

Glibenclamide

Glibenclamide is reported as an ingredient of Glibenclamida in the following countries:

• Chile


• Colombia


• Ecuador


• Venezuela

International Drug Name Search

Carafen

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Carafen

Ammonium Chloride

Ammonium Chloride is reported as an ingredient of Carafen in the following countries:

• United States

Caramiphen

Caramiphen is reported as an ingredient of Carafen in the following countries:

• United States

International Drug Name Search