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


RE Benzoyl Peroxide Cream 8.5%

BENZOYL PEROXIDE  - benzoyl peroxide cream 
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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RE Benzoyl Peroxide Cream 8.5%

DESCRIPTION:

RE Benzoyl Peroxide Cream is a topical preparation containing benzoyl peroxide as the active ingredient incorporated into a series of microscopic concentric vesicules of oil and water. This system results in the release of the active ingredient being released into the skin over a sustained period of time.

ACTIVE INGREDIENT:

Benzoyl peroxide 3.5%, 5.5%, and 8.5%, respectively.

INACTIVE INGREDIENTS:

Cetyl Alcohol, Laureth-7, C13-14 Isoparaffin, Cetearyl Alcohol (and) PEG-3 Distearoylamidoethylmonium Methosulfate (and) Polysorbate 60, Ethylhexyl Palmitate, Glyceryl Dilaurate, Stearyl Alcohol, Methylparaben, Propylparaben, Purified Water, Magnesium Aluminum Silicate, Silica, Sorbitol Solution, Sodium Lauryl Sulfate, Xanthan Gum, Polyacrylamide, Glycerin, Citric Acid, Sodium Citrate.

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:

RE Benzoyl Peroxide Cream is indicated for use in the topical treatment of mild to moderate acne vulgaris.

CONTRAINDICATIONS:

RE Benzoyl Peroxide Cream 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 (SEE WARNINGS):

General: For external use only. Avoid contact with eyes and mucous membranes. If severe irritation develops, discontinue use and seek appropriate therapy.

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:

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:

RE Benzoyl Peroxide Cream should be applied once or twice daily to the affected area. To achieve desired results, frequency can be adjusted. Gently cleanse the affected areas prior to application. By the third week of therapy, clinically visible improvement will normally occur. After approximately eight to twelve weeks of use, maximum lesion reduction may be expected. Maintain a satisfactory clinical response by continuing use of the drug as advised by your physician.

HOW SUPPLIED:

RE Benzoyl Peroxide Cream is supplied in 45 gram tubes, as:
RE Benzoyl Peroxide Cream 3.5%, NDC # 68032-289-45
RE Benzoyl Peroxide Cream 5.5%, NDC # 68032-290-45
RE Benzoyl Peroxide Cream 8.5%, NDC # 68032-291-45.

Store between 15-30°C (59-86°F).

PACKAGING

tube1

BENZOYL PEROXIDE 
benzoyl peroxide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-291
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 85 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL  
LAURETH-7  
C13-14 ISOPARAFFIN  
CETOSTEARYL ALCOHOL  
POLYSORBATE 60  
ETHYLHEXYL PALMITATE  
STEARYL ALCOHOL  
METHYLPARABEN  
PROPYLPARABEN  
WATER  
MAGNESIUM ALUMINUM SILICATE  
SILICON DIOXIDE  
SORBITOL  
SODIUM LAURYL SULFATE  
XANTHAN GUM  
GLYCERIN  
CITRIC ACID MONOHYDRATE  
SODIUM CITRATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-291-45 45 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/14/2008 02/28/2012

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

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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