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ProvayBlue®

ProvayBlue Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Revision Date: 09/11/ 2017 Date of issue: 09/11/ 2017 Version: SECTION 1: IDENTIFICATION Product Identifier Product Form: Solution for injection Product Name: ProvayBlue USP Product Codes: : 0517-0374-05 Intended Use of the Product PROVAYBLUE (methylene blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Name, Address, and Telephone of the Responsible Party Company Supplier Distributor Provepharm 22 rue Marc Donadille 13013 Marseille, France t: +33 (0)491 086 942 f: +33 (0)491 086 901 contact: CENEXI 52 rue Marcel et Jacques Gaucher BP 41 94120 Fontenay sous-bois, France Luitpold Pharmaceuticals, Inc.

ProvayBlue® Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations 09/11/2017 EN (English US) 2/5

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