Benzamycin (erythromycin and benzoyl peroxide)

PRODUCT MONOGRAPH BENZAMYCIN ® Erythromycin and Benzoyl Peroxide Topical Gel, USP Acne Therapy sanofi-aventis Canada Inc. Date of Revision: 2150 St. Elzear Blvd. West May 31, 2006 Laval, Quebec H7L 4A8 Submission Control No.: 106118 s-a Version 1.2 dated September 25, 2008

Guidance for Industry

Guidance for Industry Topical Acne Drug Products for Over-the-Counter Human Use — Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective Small Entity Compliance Guide U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation ...

BenzaClin® Topical Gel (clindamycin - benzoyl peroxide gel)

BenzaClin ® Topical Gel Rx Only (clindamycin - benzoyl peroxide gel) Topical Gel: clindamycin (1%) as clindamycin phosphate, benzoyl peroxide (5%)

Benzamycin® Topical Gel

Benzamycin Topical Gel (erythromycin-benzoyl peroxide gel) Topical Gel: erythromycin (3%), benzoyl peroxide (5%) For Dermatological Use Only – Not for Ophthalmic Use


BENZOYL PEROXIDE Data were last reviewed in IARC (1985) and the compound was classified in IARC Monographs Supplement 7 (1987). 1. Exposure Data 1.1 Chemical and physical data 1.1.1 Nomenclature Chem. Abstr.

CAS N°: 94-36-0

oecd sids benzoyl peroxide unep publications 1 foreword introduction benzoyl peroxide cas n°: 94-36-0


BENZOYL PEROXIDE: METHOD 5009, Issue 2, dated 15 August 1994 - Page 2 of 3 REAGENTS: 1. Benzoyl peroxide, 99% pure.* 2. Ethyl ether, purified, without stabilizer.*

Material Safety Data Sheet Benzoyl peroxide MSDS

p. 1 2 2 2 Health Fire Reactivity Personal Protection 3 1 3 E Material Safety Data Sheet Benzoyl peroxide MSDS Section 1: Chemical Product and Company Identification Product Name: Benzoyl peroxide Catalog Codes: SLB1051 CAS#: 94-36-0 RTECS: DM8575000 TSCA: TSCA 8(b) inventory: Benzoyl peroxide ...


O FFICE OF C LINICAL P HARMACOLOGY R EVIEW NDA 50-819 Submission Letter Date(s) 12/21/2007, 2/19/2008 PDUFA Due Date 10/26/08 Brand Name Acanya Gel (pending brand name approval) Generic Name Aqueous gel containing clindamycin phosphate 1.2% and benzoyl peroxide 2.5% Primary Reviewer * Jang-Ik ...

Benzoyl Peroxide Wash 2

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.

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