Clease And Treat
FDA Label NDC 23710-052

Cleanse & Treat
(benzoyl peroxide pad and salicylic acid pad)

Rx Only

Cleanse & Treat contains two separate and distinct non-woven pads enclosed in a heat-sealed foil pack compartmentalized from one another within the foil pack by filmstock. One non-woven pad bears a preparation consisting of 5% benzoyl peroxide and the following inactive ingredients: ammonium lauryl sulfate, carbomer, disodium cocoamphodiacetate, DMDM hydantoin, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium chloride, sodium hydroxide. The other non-woven pad bears a preparation consisting of 2% salicylic acid and the following inactive ingredients: ammonium lauryl sulfate, cellulose gum, disodium ricinoleamido MEA-sulfosuccinate, DMDM hydantoin, propylene glycol monoricinoleate, purified water, sodium citrate dihydrate.

Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. It has an empirical formula of C14H10O4 with a molecular weight of 242.23. Benzoyl peroxide has the following molecular structure:

Chemical-structure (Cleanse And Treat 1)

Salicylic acid is the 2 hydroxy derivative of benzoic aid. It has an empirical formula of C7H6O3 with a molecular weight of 138.12. Salicylic acid has the following molecular structure:

Chemical-structure (Cleanse And Treat 2)

The exact method of action of benzoyl peroxide in acne vulgaris is not known, however, its antibacterial activity against Propionibacterium acnes, together with its mild keratolytic effect, is believed to be its significant mode of action.

Cleanse & Treat is indicated for the topical treatment of acne vulgaris.

Cleanse & Treat is contraindicated in patients with a history of hypersensitivity to any of its ingredients.

Allergic contact dermatitis and/or dryness have been reported with topical benzoyl peroxide and salicylic acid, both when used separately and in combination with one another.

If excessive scaling, erythema or edema occurs, patients should discontinue use of Cleanse & Treat and consult with their physician.

Unless otherwise directed by a prescribing physician, patients should apply one salicylic acid pad and one benzoyl peroxide pad to affected areas twice per day. Cleanse & Treat is a leave-on acne treatment, intended for use without water or additional cleansers unless otherwise directed by your physician.

Each Cleanse & Treat packette consists of one 0.8 g. 5% benzoyl peroxide pad and one 0.5 g. 2% salicylic acid pad, with each pad separated from one another by filmstock and both pads enclosed together in an individual heat-sealed foil pack bearing the NDC Number 23710-052-02.

Store at 15°-25° C (59°-77° F)

Cleanse & Treat covered by US Patents: 5,254,109; 5,417,674; and 5,562,642.

Quinnova Pharmaceuticals, Inc., Newtown, PA 18940, (877) 660-6263, www.QUINNOVA.com.

Prescribing Information as of April 2008.

Company-logo (Cleanse And Treat 3)