2/2/2015 CFRCodeofFederalRegulationsTitle21

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CFRCodeofFederalRegulationsTitle21
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[CodeofFederalRegulations]
[Title21,Volume5]
[RevisedasofApril1,2014]
[CITE:21CFR355.50]

TITLE21FOODANDDRUGS
CHAPTERIFOODANDDRUGADMINISTRATION
DEPARTMENTOFHEALTHANDHUMANSERVICES
SUBCHAPTERDDRUGSFORHUMANUSE
PART355ANTICARIESDRUGPRODUCTSFOROVERTHECOUNTERHUMANUSE
SubpartCLabeling
Sec.355.50Labelingofanticariesdrugproducts.

(a)Statementofidentity.Thelabelingoftheproductcontainsthe
establishednameofthedrug,ifany,andidentifiestheproductas:
(selectoneorbothofthefollowing:`anticavity'or`fluoride')
(selectoneofthefollowingasappropriate:"dentifrice,"
"toothpaste,""toothpolish,""toothpowder"(optional:"dental")
"preventivetreatmentgel"or(optional:"treatment"or"dental"))
(selectoneofthefollowing:"rinse,""concentratedsolution,""rinse
powder,"or"rinseeffervescenttablets").Theword"mouthwash"maybe
substitutedfortheword"rinse"inthisstatementofidentityifthe
productalsohasacosmeticuse,asdefinedinsection201(i)ofthe
FederalFood,Drug,andCosmeticAct(theact)(21U.S.C.321(i)).
(b)Indication.Thelabelingoftheproductstates,undertheheading
"Indication,"thefollowing:"Aidsinthepreventionofdental(select
oneofthefollowing:"cavities,""decay,""caries(decay),"or
"caries(cavities)").Othertruthfulandnonmisleadingstatements,
describingonlytheindicationforusethathasbeenestablishedand
listedinthisparagraph(b),mayalsobeused,asprovidedin
330.1(c)(2)ofthischapter,subjecttotheprovisionsofsection502
oftheFederalFood,Drug,andCosmeticAct(theact)relatingto
misbrandingandtheprohibitioninsection301(d)oftheactagainst
theintroductionordeliveryforintroductionintointerstatecommerce
ofunapprovednewdrugsinviolationofsection505(a)oftheact.
(c)Warning.Thelabelingoftheproductcontainsthefollowing
warningundertheheading"Warning":
(1)Forallfluoridedentifrice(gel,paste,andpowder)products.
"Keepoutofreachofchildrenunder6yearsofage.[highlightedin
boldtype]Ifmorethanusedforbrushingisaccidentallyswallowed,
getmedicalhelporcontactaPoisonControlCenterrightaway."These
warningsshallbeusedinplaceofthegeneralwarningstatements
requiredby330.1(g)ofthischapter.
(2)Forallfluoriderinseandpreventivetreatmentgelproducts.
"Keepoutofreachofchildren.[highlightedinboldtype]Ifmore
thanusedfor"(selectappropriateword:"brushing"or"rinsing")"is
accidentallyswallowed,getmedicalhelporcontactaPoisonControl
Centerrightaway."Thesewarningsshallbeusedinplaceofthe
generalwarningstatementsrequiredby330.1(g)ofthischapter.
(d)Directions.Thelabelingoftheproductcontainsthefollowing
statementsundertheheading"Directions":

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2/2/2015 CFRCodeofFederalRegulationsTitle21

(1)Foranticariesdentifriceproducts(i)Gelorpastedosageform
withatheoreticaltotalfluorineconcentrationof850to1,150ppm
identifiedin355.10(a)(1),(b)(1),and(c)(1).Adultsandchildren2
yearsofageandolder:Brushteeththoroughly,preferablyaftereach
mealoratleasttwiceaday,orasdirectedbyadentistordoctor.
Instructchildrenunder6yearsofageingoodbrushingandrinsing
habits(tominimizeswallowing).Supervisechildrenasnecessaryuntil
capableofusingwithoutsupervision.Childrenunder2yearsofage:
Consultadentistordoctor.
(ii)Gelorpastedosageformwithatheoreticaltotalfluorine
concentrationof1,500ppmidentifiedin355.10(b)(2).Adultsand
children6yearsofageandolder:Brushteeththoroughly,preferably
aftereachmealoratleasttwiceaday,orasdirectedbyadentist
ordoctor.Instructchildrenunder12yearsofageingoodbrushing
andrinsinghabits(tominimizeswallowing).Supervisechildrenas
necessaryuntilcapableofusingwithoutsupervision.Childrenunder6
yearsofage:Donotuseunlessdirectedbyadentistordoctor.
(iii)Powdereddosageformwithatheoreticaltotalfluorine
concentrationof850to1,150ppmidentifiedin355.10(a)(2).Adults
andchildren6yearsofageandolder:Applypowdertoawet
toothbrushcompletelycoverallbristles.Brushforatleast30
seconds.Reapplypowderasbeforeandbrushagain.Rinseandspitout
thoroughly.Brushteeth,preferablyaftereachmealoratleasttwice
aday,orasdirectedbyadentistordoctor.Instructchildrenunder
12yearsofageingoodbrushingandrinsinghabits(tominimize
swallowing).Supervisechildrenasnecessaryuntilcapableofusing
withoutsupervision.Childrenunder6yearsofage:Donotuseunless
directedbyadentistordoctor.
(2)Foranticariestreatmentrinseproducts(i)Foracidulated
phosphatefluoridesolutioncontaining0.02percentfluorideion,
sodiumfluoride0.05percent,sodiumfluorideconcentrate,and
stannousfluorideconcentrateidentifiedin355.10(a)(3)(i),(a)(3)
(iv),(a)(3)(v),and(c)(3).Adultsandchildren6yearsofageand
older:Useonceadayafterbrushingyourteethwithatoothpaste.
Vigorouslyswish10millilitersofrinsebetweenyourteethfor1
minuteandthenspitout.Donotswallowtherinse.Donoteator
drinkfor30minutesafterrinsing.Instructchildrenunder12years
ofageingoodrinsinghabits(tominimizeswallowing).Supervise
childrenasnecessaryuntilcapableofusingwithoutsupervision.
Childrenunder6yearsofage:Consultadentistordoctor.
(ii)Foracidulatedphosphatefluoridesolutioncontaining0.01
percentfluorideionandsodiumfluoride0.02percentaqueoussolution
identifiedin355.10(a)(3)(ii)and(a)(3)(iii).Adultsandchildren6
yearsofageandolder:Usetwiceadayafterbrushingyourteethwith
atoothpaste.Vigorouslyswish10millilitersofrinsebetweenyour
teethfor1minuteandthenspitout.Donotswallowtherinse.Donot
eatordrinkfor30minutesafterrinsing.Instructchildrenunder12
yearsofageingoodrinsinghabits(tominimizeswallowing).
Supervisechildrenasnecessaryuntilcapableofusingwithout
supervision.Childrenunder6yearsofage:consultadentistor
doctor.
(3)Forstannousfluoridetreatmentrinseproducts.(i)"Use
immediatelyafterpreparingtherinse."
(ii)Forpowderoreffervescenttabletsusedtopreparetreatment
rinses."Donotuseasarinseuntilallthe"(selectoneofthe
following:"powder"or"tablet")"hasdissolved."
(4)Foranticariespreventivetreatmentgelproducts.Adultsand
children6yearsofageandolder:Useonceadayafterbrushingyour
teethwithatoothpaste.Applythegeltoyourteethandbrush
thoroughly.Allowthegeltoremainonyourteethfor1minuteand
thenspitout.Donotswallowthegel.Donoteatordrinkfor30

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2/2/2015 CFRCodeofFederalRegulationsTitle21
minutesafterbrushing.Instructchildrenunder12yearsofageinthe
useofthisproduct(tominimizeswallowing).Supervisechildrenas
necessaryuntilcapableofusingwithoutsupervision.Childrenunder6
yearsofage:consultadentistordoctor.
(5)Forallconcentratedtreatmentrinsesolutions,powders,and
effervescenttablets.Thefollowingstatementshallappearasthe
firststatementunderdirections:"Donotusebeforemixingwith
water."
(e)Additionallabelingstatementsforanticariesdrugproducts.The
followingstatementsneednotappearunderwarnings,butarerequired
toappearonthelabelofanticariesdrugsproductsasapplicable.
(1)Forallpreventivetreatmentgels."Thisisa(n)"(selectoneor
bothofthefollowing:"anticavity"or"fluoride")"preventive
treatmentgel,notatoothpaste.Readdirectionscarefullybefore
using."
(2)Forallstannousfluoridetreatmentrinse,preventivetreatment
gel,anddentifriceproducts."Thisproductmayproducesurface
stainingoftheteeth.Adequatetoothbrushingmaypreventthesestains
whicharenotharmfulorpermanentandmayberemovedbyyour
dentist."
(f)Optionaladditionallabelingstatements(1)Forfluoride
treatmentrinsesandpreventivetreatmentgels.Thefollowinglabeling
statementmayappearintherequiredboxedareadesignated"APPROVED
USES":"Thecombineddailyuseofafluoridepreventivetreatment"
(selectoneofthefollowing:"rinse"or"gel")"andafluoride
toothpastecanhelpreducetheincidenceofdentalcavities."
(2)Fordentifriceproductscontaining1,500ppmtheoreticaltotal
fluorine."Adultsandchildrenover6yearsofagemaywishtouse
thisextrastrengthfluoridedentifriceiftheyresideina
nonfluoridatedareaoriftheyhaveagreatertendencytodevelop
cavities."
[60FR52507,Oct.6,199560FR57927,Nov.24,199561FR51187,
Oct.7,199664FR13296,Mar.17,1999]

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