BENPROX
-
benzoyl peroxide gel
BENPROX
-
benzoyl peroxide gel
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:
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 |
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| 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 |
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| 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 |
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| 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 | |