BENPROX
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benzoyl peroxide gel
BENPROX
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benzoyl peroxide liquid
River's Edge Pharmaceuticals, LLC
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BENPROX 2.75% Gel, BENPROX 5.25% Gel, and BENPROX 5.25% WashDESCRIPTION
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:
BENPROX 5.25% Gel PRODUCT PACKAGING:
BENPROX 5.25% Wash PRODUCT PACKAGING:
| BENPROX
benzoyl peroxide gel |
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| 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 |
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| 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 |
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| 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 | |