Generic Name: benzoyl peroxide
Dosage Form: topical solution
Peroderm 7 Wash
DESCRIPTION: PerodermTM Wash (7% Benzoyl Peroxide) is intended for topical administration and contains Benzoyl Peroxide for use in the treatment of acne vulgaris. Benzoyl Peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl Peroxide (C14H10O4) is represented by the following chemical structure:
O=C-O-O-C=O
Each mL of PerodermTM Wash (7% Benzoyl Peroxide) contains 70mg of Benzoyl Peroxide in an emulsion based formulation consisting of: aloe, carbomer interpolymer type A, cetyl alcohol, disodium oleamido MEA-sulfosuccinate, edetate disodium, glycerin, glyceryl stearate/PEG-100 stearate, green tea, laureth-12, magnesium aluminum silicate, propylene glycol, purified water, sodium coco-sulfate, sodium lauroamphoacetate, xanthan gum.
CLINICAL PHARMACOLOGY: The mechanism of action of Benzoyl Peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with Benzoyl Peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of Benzoyl Peroxide, although it has been shown that Benzoyl Peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by Benzoyl Peroxide in humans.
INDICATIONS AND USAGE:
PerodermTM Wash (7% Benzoyl Peroxide) is indicated for the topical treatment of acne vulgaris.
CONTRAINDICATIONS: These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.
WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen.
PRECAUTIONS: General: For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.
Information for Patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Data from several studies employing a strain of mice that is highly susceptible to developing cancer suggest that Benzoyl Peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl Peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.
Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with Benzoyl Peroxide. It is 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. There are no available data on the effect of Benzoyl Peroxide on the later growth, development and functional maturation of the unborn child. If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.
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 have not been established.
ADVERSE REACTIONS: Allergic contact dermatitis and dryness have been reported with topical Benzoyl Peroxide therapy.
OVERDOSAGE: If excessive scaling, erythema or edema occurs, the use of this prepartion should be discontinued. To Hasten resolution of the adverse effcts, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be tried cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.
DOSAGE AND ADMINISTRATION:
PerodermTM Wash (7% Benzoyl Peroxide): Apply to affected areas once or twice a day, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin to 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, control by rinsing off cleanser sooner or using less often.
HOW SUPPLIED:
PerodermTM Wash (7% Benzoyl Peroxide) is supplied in a 16oz bottle, NDC 51991-699-16.
Store at a 25° C (77°F);excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room temperature. Protect from freezing.
Dispense in original container.
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
All prescription substitutions using this product shall be pursuant to state statues as applicable. this is not n Orange Book product.
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 12/15/2009 | ||
| Labeler - Breckenridge Pharmaceutical inc. (150554335) |
| Registrant - Groupe Parima inc. (252437850) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Groupe Parima inc. | 252437850 | manufacture | |
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