SUPEROL KPO® GLYCERIN, USP*/FCC/EP* SUPEROL NK® GLYCERIN, USP*/FCC STAR KPO® GLYCERIN STAR NK® GLYCERIN MOON OU® GLYCERIN, USP*/FCC *Excipient Use Only Regulatory and Standards Regulatory Items/Standards International Nomenclature for Cosmetic Ingredient (INCI) Name Chemical Abstracts Number (CAS No.) EINECS Number US FDA Regulatory Status Details FDA GRAS Clearance No.: 21 CFR 182.1320 Other Food Additive Clearance: FDA 21CFR 175.105; 175.300; 175.320; 175.380; 175.390; 176.179; 176.210; 177.1210; 177.2420; 178.3120; 182.90; 182.99 P&G’s “National Drug Labelers Code” (NDC Number) GRAS F.E.M.A Number Harmonized Tariff Code Number Canadian Food and Drug Regulations, Part B GMP Quality Assurance Regulatory and Standards Glycerin 56-81-5 200-289-5 GRAS - Generally recognized as safe when used according with good manufacturing practice. 037000 2525 2905.45 Division 16, Table XV, number 8 (glycerin) Division 16, Table VIII, G.3 (glycerol) Follows GMP procedures Procter & Gamble’s USP/FCC grade (for excipient use only) glycerin brands are manufactured in accordance with IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients and FCC GMP’s for food chemicals. COPYRIGHT © 2012 P&G CHEMICALS PAGE 1 OF 2 Drug Master File (DMF) Number This is not applicable to our line of glycerin. A DMF is a means of submitting Confidential Business Information (CBI) data to US FDA for use in support of Investigational New Drug (IND) or New Drug Application (NDA) submissions, etc. A DMF is not required by law or FDA regulation, and submission is voluntary. Since P&G Chemicals’ glycerin is for excipient use only, P&G Chemicals has not applied for a DMF. Compendia Conformance As stated in the name of our products, our line of glycerin above meets the compendia requirement of the standards below:1 Brand SUPEROL KPO® MOON OU® SUPEROL NK® Meets Standard US Pharmacopeia* Food Chemical Codex European Pharmacopeia* US Pharmacopeia* Food Chemical Codex Conformance Expected British Pharmacopoeia Japanese Pharmacopoeia European Pharmacopoeia British Pharmacopoeia Japanese Pharmacopoeia * For Excipient Use Only 1 IMPORTANT NOTE This technical product information, while believed to be accurate and reliable, is given without guarantee or warranty of any kind expressed or implied. Purchaser assumes all risk in acting on this information provided by Procter & Gamble representatives. Individual requirements vary, and each purchaser is urged to perform their own tests, experiments and investigations in the use of Procter and Gamble products and for purposes of determining compliance with applicable Federal, State and local laws and regulations. Nothing contained herein shall be construed as a recommendation to use any product in connection with existing patents covering any material or its use. Moreover, no license is to be implied under any Procter & Gamble patents relating to uses of the above described chemicals other than those uses specifically mentioned herein Regulatory and Standards COPYRIGHT © 2012 P&G CHEMICALS PAGE 2 OF 2