NeoBenz Micro Plus Pack

Product Type: HUMAN PRESCRIPTION DRUG

Route:

Dosage Form:

NDC: 67402-021

Application:

Effective: 20100512

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.

V. WARNINGS When using this product, avoid unnecessary sun exposure and use a sunscreen.

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