NEOBENZ MICRO PLUS PACK

I. DESCRIPTION NeoBenz® Micro 5.5% cream, NeoBenz ® Micro SD 5.5% single dose cream pre-filled sponge applicator and NeoBenz® Micro Wash 7% are topical preparations containing benzoyl peroxide as the active ingredient incorporated into patented porous microspheres ( MICROSPONGE ®* delivery 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 and absorb natural skin oils 2 . Ingredients for the cream and SD include: water, glycerin, ethylhexyl palmitate, sorbitol, cetyl alcohol, glyceryl ditaurate, stealryl alcohol, magnesium aluminum silicate, methyl methacrylate/glycol dimethacrylate crosspolymer, silica, citric acid, xanthan gum, methylparaben, sodium citrate, propyIparaben, polyacrylamide, C13-14 isoparaffin, laureth-7, sodium lauryl sulfate. Ingredients for the Wash include citric acid, cocamidopropyl betaine, cocamine oxide, disodium laureth sulfosuccinate, edetate disodium, fragrance, glycerin, hydrogenated castor oil, hypromellose, magnesium aluminum silicate, methyl methacrylate/Glycol dimethacrylate crosspolymer, methylparaben, PEG-150 pentaerythrityl tetrastearate (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 (C 14 H 10 O 4 ) is represented by the following structure: Benzoyl-Peroxide-Structural-Formula

III. INDICATIONS AND USAGE NeoBenz® Micro, NeoBenz® Micro SD and NeoBenz® Micro Wash are indicated for use in the topical treatment of mild to moderated acne vulgaris.

IX. DOSAGE AND ADMINISTRATION NeoBenz® Micro, NeoBenz® Micro SD and NeoBenz® Micro Wash should be used once or twice daily on the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. If yo u see medication or white residue on skin after application of NeoBenz® Micro or NeoBenz® Micro SD, you are applying too much. Gentle cleansing of the affected areas with a mild cleanser prior to application of NeoBenz® Micro or NeoBenz® Micro SD may be beneficial. Clinically visible improvement will normally occur by the third week if therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks for drug use. Continuing use of the drug us normally required to maintain a satisfactory clinical response. NeoBenz® Micro : If applying to the entire face, apply a pea-sized amount of NeoBenz® Micro to one fingertip and dab onto cheeks, forehead and chin. Spread evenly onto entire face. NeoBenz® Micro S D : Firmly squeeze applicator until seal between applicator and sponge has broken. Apply medication by rubbing sponge on small circular motions on affected areas. Dispose of each applicator after single use only. NeoBenz® Micro Wash : Shake well before using. Wet skin areas to be treated; apply NeoBenz® Micro Wash by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry.

IV. CONTRAINDICATIONS NeoBenz® Micro, NeoBenz® Micro SD and NeoBenz® Micro Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

VII . ADVERSE REACTIONS Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

Store between 15 o - 25 o C (59 o - 77 o F)