Benzac AC Gel: Indications, Dosage, Precautions, Adverse Effects
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Benzac AC Gel - Product Information

Manufacture: Galderma Laboratories
Country: Australia
Condition: Acne, Acne rosacea (Rosacea), Acne Vulgaris (Acne)
Class: Topical acne agents
Form: Cream, gel, liniment or balm, lotion, ointment, etc
Ingredients: Benzoyl peroxide, docusate sodium, disodium edentate, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerol, silicon dioxide, sodium hydroxide and purified water

water base gel

(benzoyl peroxide gel)

(benzoyl peroxide)

Description

Benzac AC 5 and 10 (ben­zoyl peroxide gel) and Benzac AC Wash 5 and 10 (benzoyl peroxide) are topical, water-base, benzoyl peroxide containing prepara­tions for use in the treatment of acne vul­garis. Benzoyl peroxide is an oxidizing agent which possesses antibacterial properties and is classified as a keratolytic. Benzoyl perox­ide (C14H1004) is represented by the following chemical structure:

Benzac AC 5 and Benzac AC 10 contain, respectively, benzoyl peroxide 5% and 10% as the active ingredient in a gel base con­taining acrylates copolymer, carbomer 940, docusate sodium, edetate disodium, glycerin, poloxamer 182, propylene glycol, purified water, silicon dioxide, and sodium hydroxide. May contain citric acid to adjust pH.

Benzac AC Wash 5 and Benzac AC Wash 10 contain, respectively, benzoyl peroxide 5% and 10% as the active ingredient in a vehicle consisting of acrylates copolymer, carbomer 940, glycerin, purified water, sodi­um C14-16 olefin sulfonate, and sodium hydroxide. May contain citric acid to adjust pH.

Сlinical 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 a 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

Benzac AC 5 and 10 and Benzac AC Wash 5 and 10 are indicated for topical treatment of acne vul­garis.

Contraindication

These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

Precautions

General

For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After the 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. Avoid contact with hair, fabric or carpet. Benzoyl peroxide will cause bleaching. When using this product, avoid unnecessary sun exposure and use a sunscreen. 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 are 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.

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 occur, the use of this prepara­tion 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

Benzac AC 5 or 10 should be applied once or twice daily to cover affected areas after washing with a mild cleanser and water.

Benzac AC Wash 5 or 10. Wash once or twice daily, avoiding contact with the eyes and mucous membranes. Wet the area of application. Apply Benzac AC Wash 5 or 10 to the hands and wash the affected areas. Rinse with water and pat dry.

How Supplied

Benzac AC 5 Water Base Gel 60 g tubes — NDC 0299-3625-60

Benzac AC 10 Water Base Gel 60 g tubes — NDC 0299-3630-60

Benzac AC Wash 5

8 oz. plastic bottles — NDC 0299-3640-08

Benzac AC Wash 10

8 oz. plastic bottles — NDC 0299-3645-08

Storage

Store Benzac AC and Benzac AC Wash at controlled room tem­perature 68°F to 77°F (20°C to 25°C).

Marketed By

GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177, USA

Mfd. By

DPT Laboratories, Ltd.

San Antonio, Texas 78215, USA