BENZOYL PEROXIDE
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benzoyl peroxide liquid
River's Edge Pharmaceuticals, LLC
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Benzoyl Peroxide Wash 7%The use of tretinoin and hydroquinone topical preparations should be avoided when using this product.
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 a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman 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 a nursing woman.
Pediatric Use
Safety and effectiveness in children below the age of 12 have not been established.
If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. 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.
Benzoyl Peroxide Wash 7% 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 into the skin over a sustained period of time. Ingredients include: Citric Acid, cocamidopropyl betaine, cocamine oxide, disodium laureth sulfosuccinate, disodium EDTA, Fragrance Lemon, Glycerin, Hydrogenated Castor Oil, Hypromellose, Magnesium Aluminum Silicate, Cetearyl Alcohol and PEG-3 Distearoylamidoethylmonium Methosulfate and Polysorbate 60, Methylparaben, PEG-150 Pentaerythrityl Tetrastearate and Aqua and PEG-6 Caprylic/Capric Glycerides, PEG-40 Hydrogenated Castor Oil, Poloxamer 182, Purified Water and Xanthan Gum.
Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic.
Benzoyl peroxide (C14H10O4) is represented by the following structure:
Benzoyl Peroxide Wash 7% is supplied as follows:
SIZE: 6.35 oz. (180 g) bottle
NDC #: 68032-420-18
Storage Conditions:
Store between 15-30° C (59°- 86°F). Protect from freezing.
GENERAL INFORMATION
Patients should be advised of the following:
• Avoid contact with eyes, eyelids, lips, and mucous membranes while using benzoyl peroxide. If accidental contact occurs, rinse with water.
• If excessive irritation develops, discontinue use and consult their physician.
• When using this product, avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with hair, fabrics, or carpeting as benzoyl peroxide will cause bleaching or discoloration.
ADVERSE REACTIONS
Patients should be informed that treatment with topical benzoyl peroxide may lead to adverse reactions that include allergic contact dermatitis and dryness.
EXCESSIVE USE OF TOPICAL BENZOYL PEROXIDE
Patients should be advised to discontinue use and consult their physician if excessive scaling, erythema, or edema occurs. Advise the use of cool compresses 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.
Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 07/09 420-115
BENZOYL PEROXIDE
benzoyl peroxide 7% liquid |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved drug other | 06/01/2009 |
Labeler - River's Edge Pharmaceuticals, LLC (133879135) |