Neobenz Micro Benzoyl Peroxide Wash
Generic Name: benzoyl peroxide
Dosage Form: lotion
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
(benzoyl peroxide cream)
NeoBenz® Micro SD
(benzoyl peroxide cream)
NeoBenz® Micro Wash
FOR EXTERNAL USE ONLY.
Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following structure:
II. CLINICAL PHARMACOLOGYThe 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.
III. INDICATIONS AND USAGENeoBenz® Micro, NeoBenz® Micro SD and NeoBenz® Micro Wash are indicated for use in the topical treatment of mild to moderated acne vulgaris.
IV. CONTRAINDICATIONSNeoBenz® 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.
VI. PRECAUTIONS(SEE WARNINGS)
General– For external use only. Avoid contact with eyes and mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy.
VII . ADVERSE REACTIONSAllergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
VIII. OVERDOSAGEIf 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.
IX. DOSAGE AND ADMINISTRATIONNeoBenz® 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 you 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 SD: 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.
X. HOW SUPPLIEDNeoBenz® Micro is supplied as follows:
SIZE: 45 gram tube
(3.5% benzoyl peroxide cream): 67402-020-45
(5.5% benzoyl peroxide cream): 67402-021-45
NeoBenz® Micro SD is supplied as follows:
SIZE: 1 box of thirty 0.5 gram applicators
(5.5% benzoyl peroxide cream): 67402-021-06
NeoBenz® Micro Wash is supplied as follows:
SIZE: 180 gram tottle
(benzoyl peroxide 7%): 67402-027-17
REFERENCES1. Wester RC, Patel R, Nacht S, Leyden J, Melendres J, Maibach H. Controlled release of benzoyl peroxide from a porous microsphere polymeric system can reduce topical irritancy. J. Am. Acad. Dermatol. 1991;24; 720-726.
2. Meyer R. Rosen (ed.), Delivery System Handbook for Personal care and Cosmetic Products, 332-352 (2005).
Covered by Us Patents: 4,690,825; 5,145,675; 5,879,716; 6,007,364.
*MICROSPONGE® is a registered trademark of AMCOL Health and Beauty Solutions, Inc, a subsidiary of AMCOL International Corporation.
129008 December 2008
NeoBenz Micro Wash, Benzoyl Peroxide 7%
|NEOBENZ(R) MICRO BENZOYL PEROXIDE WASH, 7%
benzoyl peroxide, 7% lotion
|Labeler - SkinMedica Pharmaceuticals, Inc., Carlsbad, CA 92010 (124977005)|
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