Neobenz Micro Benzoyl Peroxide Wash
Name: Neobenz Micro Benzoyl Peroxide Wash
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.
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.
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. Information for Patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING OR DISCOLORATION. If excessive irritation develops, discontinue use and consult your physician. Carcinogenesis, Mutagenesis, Impairment of Fertility: Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known. Pregnancy: Category C - Animal reproduction studies have not been conducted with benzoyl peroxide. It is also 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. 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 below the age of 12 have not been established.
General– For external use only. Avoid contact with eyes and mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy. Information for Patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING OR DISCOLORATION. If excessive irritation develops, discontinue use and consult your physician. Carcinogenesis, Mutagenesis, Impairment of Fertility: Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known. Pregnancy: Category C - Animal reproduction studies have not been conducted with benzoyl peroxide. It is also 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. 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 below the age of 12 have not been established.
X. how supplied
NeoBenz® Micro is supplied as follows:
SIZE: 45 gram tube
NDC NUMBER:
(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
NDC NUMBER:
(5.5% benzoyl peroxide cream): 67402-021-06
NeoBenz® Micro Wash is supplied as follows:
SIZE: 180 gram tottle
NDC NUMBER:
(benzoyl peroxide 7%): 67402-027-17
Store between 15o - 25o C (59o - 77o F)
SIZE: 45 gram tube
NDC NUMBER:
(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
NDC NUMBER:
(5.5% benzoyl peroxide cream): 67402-021-06
NeoBenz® Micro Wash is supplied as follows:
SIZE: 180 gram tottle
NDC NUMBER:
(benzoyl peroxide 7%): 67402-027-17
Store between 15o - 25o C (59o - 77o F)
References
1. 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). Distributed by SkinMedica Pharmaceuticals, Inc., Carlsbad. CA 92010
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
P7001-03
2. Meyer R. Rosen (ed.), Delivery System Handbook for Personal care and Cosmetic Products, 332-352 (2005). Distributed by SkinMedica Pharmaceuticals, Inc., Carlsbad. CA 92010
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
P7001-03