Carbon Eczane

Carbon Eczane may be available in the countries listed below.

Ingredient matches for Carbon Eczane

Charcoal

Charcoal, Activated is reported as an ingredient of Carbon Eczane in the following countries:

• Argentina

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Gravi-Fol

Gravi-Fol may be available in the countries listed below.

Ingredient matches for Gravi-Fol

Folic Acid

Folic Acid is reported as an ingredient of Gravi-Fol in the following countries:

• Germany

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Inalacor Accuhaler

Inalacor Accuhaler may be available in the countries listed below.

Ingredient matches for Inalacor Accuhaler

Fluticasone

Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Inalacor Accuhaler in the following countries:

• Spain

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Vitasol A-D3-E

Vitasol A-D3-E may be available in the countries listed below.

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

Ingredient matches for Vitasol A-D3-E

Colecalciferol

Colecalciferol is reported as an ingredient of Vitasol A-D3-E in the following countries:

• Austria

Retinol

Retinol palmitate (a derivative of Retinol) is reported as an ingredient of Vitasol A-D3-E in the following countries:

• Austria

Tocopherol, α-

Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Vitasol A-D3-E in the following countries:

• Austria

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Cefalexina Lafedar

Cefalexina Lafedar may be available in the countries listed below.

Ingredient matches for Cefalexina Lafedar

Cefalexin

Cefalexin monohydrate (a derivative of Cefalexin) is reported as an ingredient of Cefalexina Lafedar in the following countries:

• Argentina

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Hestar

Hestar may be available in the countries listed below.

Ingredient matches for Hestar

Hetastarch

Hetastarch is reported as an ingredient of Hestar in the following countries:

• Oman

Pentalamide

Pentalamide is reported as an ingredient of Hestar in the following countries:

• Mexico

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Curoxime

Curoxime may be available in the countries listed below.

Ingredient matches for Curoxime

Cefuroxime

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

• Portugal

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Mirtazapine Qualimed

Mirtazapine Qualimed may be available in the countries listed below.

Ingredient matches for Mirtazapine Qualimed

Mirtazapine

Mirtazapine is reported as an ingredient of Mirtazapine Qualimed in the following countries:

• France

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Loperamid Heumann

Loperamid Heumann may be available in the countries listed below.

Ingredient matches for Loperamid Heumann

Loperamide

Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Loperamid Heumann in the following countries:

• Germany

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Benprox

benzoyl peroxide

Dosage Form: gel, wash
Benprox 2.75% Gel, Benprox 5.25% Gel, and Benprox 5.25% Wash

Benprox Description

Benprox Gel 2.75%, Benprox Gel 5.25% and Benprox Wash 5.25% are intended

for topical administration and contain benzoyl peroxide for the use in treating acne

vulgaris.

Benprox Gel 2.75% contains in an aqueous vehicle: Active ingredient: Benzoyl

Peroxide 2.75%. Inactive Ingredients: Water, Glycerin, PEG-8, Disodium Laureth

Sulfosuccinate, Carbomer, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract,

Allantoin, Panthenol, PPG-14 Palmeth-60 Hexyl Dicarbamate, Benzyl Alcohol,

Triethanolamine and Disodium EDTA.

Benprox Gel 5.25% contains in an aqueous vehicle: Active Ingredient: Benzoyl

Peroxide 5.25%. Inactive Ingredients: Water, Glycerin, PEG-8, Disodium Laureth

Sulfosuccinate, Carbomer, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract,

Allantoin, Panthenol, PPG-14 Palmeth-60 Hexyl Dicarbamate, Benzyl Alcohol,

Disodium EDTA and Triethanolamine.

Benprox Wash 5.25% contains in an aqueous vehicle: Active Ingredient: Benzoyl

Peroxide 5.25%. Inactive Ingredients: Water, Glycerin, Disodium Laureth

Sulfosuccinate, Cetyl Alcohol, Octoxynol-13, Glyceryl Stearate, Aloe Barbadensis

Leaf Extract, Propylene Glycol, Carbomer, Allantoin, Panthenol, Xanthan Gum,

Magnesium Aluminum Silicate, PEG-100 Stearate, PPG-14 Palmeth-60 Hexyl

Dicarbamate, Benzyl Alcohol, Sodium Hyaluronate, Sodium Citrate and

Triethanolamine.

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 treating 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:

Benprox Gel 2.75%, Benprox Gel 5.25% and Benprox

Wash 5.25% are indicated for the topical treatment of acne vulgaris.

CONTRAINDICATION:

Benprox Gel 2.75%, Benprox Gel 5.25% and Benprox

Wash 5.25% should not be used in patients who have shown hypersensitivity to

benzoyl peroxide or to any of the other ingredients in the products.

WARNINGS:

When using this product, avoid unnecessary sun exposure and use a

sunscreen.

PRECAUTIONS:

General: For external use only. Avoid contact with eyes and

mucous membranes.

Information for Patients: Avoid contact with eyes, eyelids, lips and mucous

membranes. If accidental contact occurs, rinse with water.

AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE

WILL CAUSE BLEACHING OR DISCOLORATION.

If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Benzoyl peroxide is not

considered to be a carcinogen based upon all available evidence. Data from a study

using mice known to be highly susceptible to cancer suggest that benzoyl peroxide

may act as a tumor promoter. The clinical significance of the findings is not known.

Pregnancy:

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 pregnant women or can affect fertility.

Benzoyl peroxide should be used by pregnant women 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 nursing women.

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.

Call your doctor for medical advice about side effects. You may report side

effects to the FDA at 1-800-FDA-1088.

OVERDOSAGE:

If excessive scaling, erythema or edema occurs, the use of these

preparations should be discontinued. Cool compresses may be used to hasten

resolution of the adverse effects. After symptoms and signs subside, a reduced

dosage schedule may be cautiously tried if the reaction is judged to be due to

excessive use and not allergenicity.

DOSAGE AND ADMINISTRATION:

Benprox Gel 2.75% and Benprox Gel 5.25% can

be applied once or twice daily to the affected areas or as directed by your physician.

Use after washing with water and a mild cleanser such as Benprox Wash 5.25%.

Benprox Wash 5.25% should be shaken well before use. The affected areas should

be washed once or twice daily or as directed by your physician. Avoid contact with

eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed,

massage gently into skin for 10 to 20 seconds, working into a full lather. Rinse

thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off

sooner or using the cleanser less often.

How is Benprox Supplied

Benprox Gel 2.75% is supplied in 50 g tubes, NDC 68032-197-50.

Benprox Gel 5.25% is supplied in 50 g tubes, NDC 68032-198-50.

Benprox Wash 5.25% is supplied in 175 g tubes, NDC 68032-199-58.

Store at 15°-25°C (59°-77°F). Protect from freezing.

Rx Only

Benprox 2.75% Gel PRODUCT PACKAGING:

FOR TOPICAL AND EXTERNAL USE ONLY

Usual Dosage: Apply to affected areas once or twice

daily or as directed by physician (see package insert).

Contains: Active Ingredient: Benzoyl Peroxide 2.75%.

Inactive Ingredients: Water, Glycerin, PEG-8, Disodium

Laureth Sulfosuccinate, Carbomer, Sodium Hyaluronate,

Aloe Barbadensis Leaf Extract, Allantoin, Panthenol,

PPG-14 Palmeth-60 Hexyl Dicarbamate, Benzyl Alcohol,

Triethanolamine and Disodium EDTA.

Cautions: Avoid contact with eyes and mucous

membranes. Avoid contact with hair or any colored

fabric or material as contact with the product will result

in bleaching or discoloration.

Warning: When using this product, avoid unnecessary

sun exposure and use a sunscreen.

See crimp for lot number and expiration date.

Store at 15°-25°C (59°-77°F). Protect from freezing.

Manufactured for: River's Edge Pharmaceuticals, LLC

Suwanee, GA 30024 Iss. 01/09 197-21

Benprox 5.25% Gel PRODUCT PACKAGING:

FOR TOPICAL AND EXTERNAL USE ONLY

Usual Dosage: Apply to affected areas once or twice

daily or as directed by physician (see package insert).

Contains: Active Ingredient: Benzoyl Peroxide 5.25%.

Inactive Ingredients: Water, Glycerin, PEG-8, Disodium

Laureth Sulfosuccinate, Carbomer, Sodium Hyaluronate,

Aloe Barbadensis Leaf Extract, Allantoin, Panthenol,

PPG-14 Palmeth-60 Hexyl Dicarbamate, Benzyl Alcohol,

Disodium EDTA and Triethanolamine.

Cautions: Avoid contact with eyes and mucous

membranes. Avoid contact with hair or any colored

fabric or material as contact with the product will result

in bleaching or discoloration.

Warning: When using this product, avoid unnecessary

sun exposure and use a sunscreen.

See crimp for lot number and expiration date.

Store at 15°-25°C (59°-77°F). Protect from freezing.

Manufactured for: River's Edge Pharmaceuticals, LLC

Suwanee, GA 30024 01/09 198-21

Benprox 5.25% Wash PRODUCT PACKAGING:

FOR TOPICAL AND EXTERNAL USE ONLY – SHAKE WELL

Usual Dosage: Wash affected areas once or twice daily or as directed

by your physician (see package insert).

Contains: Active Ingredient: Benzoyl Peroxide 5.25%.

Inactive Ingredients: Water, Glycerin, Disodium Laureth Sulfosuccinate,

Cetyl Alcohol, Octoxynol-13, Glyceryl Stearate, Aloe Barbadensis Leaf

Extract, Propylene Glycol, Carbomer, Allantoin, Panthenol, Xanthan

Gum, Magnesium Aluminum Silicate, PEG-100 Stearate, PPG-14

Palmeth-60 Hexyl Dicarbamate, Benzyl Alcohol, Sodium Hyaluronate,

Sodium Citrate and Triethanolamine.

Cautions: Avoid contact with eyes and mucous membranes. Avoid

contact with hair or any colored fabric or material as contact with the

product will result in bleaching or discoloration.

Warning: When using this product, avoid unnecessary sun exposure

and use a sunscreen.

See crimp for lot number and expiration date.

Store at 15°-25°C (59°-77°F). Protect from freezing.

Manufactured for: River's Edge Pharmaceuticals, LLC

Suwanee, GA 30024

Iss. 01/09 199-21

Benprox   benzoyl peroxide 2.75%  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-197 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 1.3 g  in 52 mL

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 68032-197-50 52 mL In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		11/01/2006

Benprox   benzoyl peroxide 5.25%  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-198 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.6 g  in 52 mL

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 68032-198-50 52 mL In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		11/01/2006

Benprox   benzoyl peroxide 5.25%  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-199 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 9.1 g  in 183.36 mL

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 68032-199-58 183.36 mL In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		11/01/2006

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Establishment
Name	Address	ID/FEI	Operations
A.I.G. Technologies, Inc.		171837367	manufacture

Revised: 10/2009River's Edge Pharmaceuticals, LLC

More Benprox resources

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

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Cefalexin monohydrate (a derivative of Cefalexin) is reported as an ingredient of Cefalexinã in the following countries:

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