Neobenz micro cream

Description

NeoBenz Micro 3.5%, 5.5% and 8.5% creams are topical preparations containing benzoyl peroxide as the active ingredient incorporated into patented porous microspheres (Microsponge * System) composed of methyl methacrylate/glycol dimethacrylate crosspolymer. This polymeric system has been shown to provide gradual release of active ingredient into the skin. 1 Other ingredients for all strengths include: water, glycerin, ethylhexyl palmitate, sorbitol, cetyl alcohol, glyceryl dilaurate, stearyl alcohol, magnesium aluminum silicate, silica, citric acid, xanthan gum, methylparaben, sodium citrate, propylparaben, polyacrylamide, C13-14 isoparaffin, laureth-7, sodium lauryl sulfate. The 8.5% cream also contains dimethicone.

Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C 14 H 10 O 4 ) is represented by the following structure:

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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

NeoBenz Micro is indicated for use in the topical treatment of mild to moderate acne vulgaris.

Contraindications

NeoBenz Micro 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. If severe irritation develops, discontinue use and institute 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: Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts 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 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.

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 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.

Dosage and Administration

NeoBenz Micro should be applied once or twice daily to the affected area. Frequency of use should be adjusted to obtain the desired clinical response. Gentle cleansing of the affected areas prior to application may be beneficial. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

How Supplied

NeoBenz Micro 3.5% Cream 45 gram tube

NDC 67402-020-45

NeoBenz Micro 5.5% Cream 45 gram tube

NDC 67402-021-45

NeoBenz Micro 8.5% Cream 45 gram tube

NDC 67402-022-45

Store at 15°-25°C (59°-77° F)

REFERENCE

  1. Data on file. Flash Topical Technologies, Cardinal Health. Somerset, NJ

Distributed by SkinMedica, Inc., Carlsbad, CA 92008

Covered by US Patents: 4,690,825; 5,145,675; 5,879,716.

* Microsponge is a registered trademark of Cardinal Health, Inc. or one of its subsidiaries.

70122B February 2004

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