Designation:D4267−07(Reapproved2015)StandardSpecificationforLabelsforSmall-Volume(100mLorLess)ParenteralDrugContainers1ThisstandardisissuedunderthefixeddesignationD4267;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverstheorientation,thesizeoftypeused,andthecontrastofthecopywiththelabelbackgroundonimmediatedrugcontainershavingavolumeof100mLorless.1.2ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.2.ReferencedDocuments2.1ASTMStandards:2D7298TestMethodforMeasurementofComparativeLeg-ibilitybyMeansofPolarizingFilterInstrumentation3.Terminology3.1Definitions:3.1.1establishedname—thedesignatednameorofficialname(commonlyreferredtoasgenericname).3.1.2immediatecontainer—thatwhichisindirectcontactwiththearticleatalltimes.33.1.3label—adisplayofwritten,printed,orgraphicmatterupontheimmediatecontainerofanyarticle.43.1.4labeling—alllabelsandotherwritten,printed,orgraphicmatter(1)uponanyarticleoranyofitscontainersorwrappers,or(2)accompanyingsucharticle53.1.5proprietaryname—manufacturer’stradeorbrandname.4.LabelRequirements4.1ContentsofLabel—Thelabelshallconsistofthefol-lowing:4.1.1Proprietarynameofdrug(optional).4.1.2Establishednameofdrug(required).Printingtheactivemoietyoftheestablishednameinaccordancewith6.1shallsuffice,example,GENTAMICINSulfateInj).4.1.3Amountofdrugperunit(forexample,milligramspermillilitre(mgpermL)orquantityofdrugpercontainerasappropriate).4.1.4Forliquids,thetotalvolumeofthecontentsshallbemarkedinalegiblemanner.4.1.5Otherinformationasrequiredbyregulationandthemanufacturer.4.2General—Manufacturersareencouragedtouseaccept-ableabbreviations(forexample,HClforhydrochloride)andminimizetheuseorsizeofothercopy(forexample,brandof,USPsolution,injection)orunrequiredpunct...
