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Name:Benprox
Manufacturer:River's Edge Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


BENPROX 2.75% Gel, BENPROX 5.25% Gel, and BENPROX 5.25% Wash

BENPROX  - benzoyl peroxide gel 
BENPROX  - benzoyl peroxide liquid 
River's Edge 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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BENPROX 2.75% Gel, BENPROX 5.25% Gel, and BENPROX 5.25% Wash

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 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:

label1

BENPROX 5.25% Gel PRODUCT PACKAGING:

label2

BENPROX 5.25% Wash PRODUCT PACKAGING:

label3


BENPROX 
benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-197
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 27.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
POLYETHYLENE GLYCOL 400  
DISODIUM LAURETH SULFOSUCCINATE  
CARBOMER 1342  
HYALURONATE SODIUM  
ALOE VERA LEAF  
ALLANTOIN  
DEXPANTHENOL  
BENZYL ALCOHOL  
EDETATE DISODIUM  
TROLAMINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-197-50 50 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2006 03/31/2011

BENPROX 
benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-198
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 52.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
POLYETHYLENE GLYCOL 400  
DISODIUM LAURETH SULFOSUCCINATE  
CARBOMER 1342  
HYALURONATE SODIUM  
ALOE VERA LEAF  
ALLANTOIN  
DEXPANTHENOL  
BENZYL ALCOHOL  
EDETATE DISODIUM  
TROLAMINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-198-50 50 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2006 10/31/2009

BENPROX 
benzoyl peroxide liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-199
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 52.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
CETYL ALCOHOL  
DISODIUM LAURETH SULFOSUCCINATE  
GLYCERYL MONOSTEARATE  
ALOE VERA LEAF  
PROPYLENE GLYCOL  
CARBOMER 1342  
ALLANTOIN  
DEXPANTHENOL  
XANTHAN GUM  
MAGNESIUM ALUMINUM SILICATE  
POLYOXYL 100 STEARATE  
BENZYL ALCOHOL  
HYALURONATE SODIUM  
SODIUM CITRATE  
TROLAMINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-199-58 175 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2006 01/31/2012

Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Establishment
Name Address ID/FEI Operations
A.I.G. Technologies, Inc. 171837367 manufacture

Revised: 12/2010 River's Edge Pharmaceuticals, LLC



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


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