M@GC Tooth Mousse"TOPICAL CREME WITH BIO-AVAILABLE CALCIUM AND PHOSPHATE

For use by or under the supervision of a dental professional in therecommended indications.

DescriptionGC Tooth Mousse is a water based creme containing RECALDENTTM.(CPP-ACP: Casein Phosphopeptide - Amorphous Calcium Phosphate).When CPP-ACP is applied in the oral environment, it will bind tobiofilms, plaque, bacteria, hydroxyapatite and soft tissue localisingbio-available calcium and phosphate.lmportant:Saliva will enhance the effectiveness of CPP-ACP and the flavour willhelp stimulate saliva flow. The longer CPP-ACP and saliva aremaintained in the mouth, the more effective the result.A topical paste containing bio-available calcium and phosphate1. Provides extra protection for teeth.2. Helps neutralize acid challenges from acidogenic bacteria in plaque.3. Helps neutralize acid challenges from other internal and external acid

sources.

CONTRAIND!CAT!ONSRECALDENITu ICPP-ACP) is derived from milk casein. Do not use thismaterial on patients with a proven or suspected milk protein allergyand/or with a sensitivity or allergy to benzoate preservatives.

DIRECTIONS FOR USEINDICATIONSa. Prior to and following in-office bleaching.b.After ultrasonic, hand scaling or root planing.c. Following professional tooth cleaning (P.T.C.).d. After application of topical fluoride.e.To provide a topical coating for patients suffering from erosion,

xerostomia or Sj0grens syndrome.f. During orthodontic treatment.g. For high risk caries patients.h. For special needs patients.ln-office application:l. Custom tray application

1. Before use rinse the custom tray thoroughly under running water.2. Extrude a generous layer of GC Tooth Mousse into the tray and

apply to the upper and / or lower teeth.3. Leave the tray undisturbed in the mouth for a minimum of 3 minutes.4. Remove the tray.5. lnstruct the patient to use the tongue to spread the remaining

GC Tooth Mousse throughout the mouth. lnstruct the patient toretain for as long as possible (1- 2 minutes) avoiding expectorationand delaying swallowing. The longer GC Tooth Mousse and salivaare maintained in the mouth, the more effective the result.

6. Ask the patient to expectorate and if possible avoid rinsing. AnyGC Tooth Mousse remaining on the surface can be left to graduallydissipate. Advise the patient not to eat or drink for 30 minutesfollowing application.

7. Any residual GC Tooth Mousse in the tray should be rinsed orbrushed off under running water immediately after use.

ll. Non tray application:1. lf necessary, remove any excess saliva on the tooth surface with a

cotton roll or pellet. However, it is NOT necessary to dry the teethwith compressed air.

2. Apply a sufficient amount of GC Tooth Mousse to the tooth surfacesusing an application swab, gloved finger or in difficult interproximalareas using an lnterproximal Tooth Cleaning Brush.

3. Leave GC Tooth Mousse undisturbed for a minimum of 3 minutes.4. Then instruct the patient to use the tongue to spread the remaining

GC Tooth Mousse throughout the mouth. Request the patient tohold in the mouth for as long as possible (an additional l -2minutes) avoiding expectoration and delaying swallowing. Thelonger GC Tooth Mousse and saliva are maintained in the mouth,the more effective the result.

5. Ask the patient to expectorate and if possible avoid rinsing. AnyGC Tooth Mousse remaining on the surface can be left to graduallydissipate. Advise the patient not to eat or drink for 30 minutesfollowing application.

At home application:lll.Day time application after tooth brushing as recommended by a

dental professional1. Apply a sufficient amount of GC Tooth Mousse to upper and lower

teeth. A pea size amount for each arch is the minimum required.The material should be applied to the tooth surfaces using a cleandry finger or cotton tip. For difficult areas (between the teeth) usean lnterproximal Tooth Cleaning Brush or dental floss coated withGC Tooth Mousse.

2. Leave GC Tooth Mousse on the teeth undisturbed for a minimum of3 minutes.

3. Then use your tongue to spread the remaining GC Tooth Moussethroughout the mouth. Hold in the mouth for as long as possible(a further 1 - 2 minutes) avoiding expectoration (spitting out) anddelaying swallowing. The longer GC Tooth Mousse and saliva aremaintained in the mouth, the more effective the result.

2. 4. Expectorate thoroughly and if possible avoid rinsing. Any3. GC Tooth Mousse remaining on the surface can be left to gradually

dissipate. Do not to eat or drink for 30 minutes following application.lV Night time application after tooth brushing as recommended by

a dental professional

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1. Apply a sufficient amount of GC Tooth Mousse to the upper andlower teeth. A pea size amount for each arch is the minimumrequired. The material should be applied to the tooth surfaces usinga clean dry finger or cotton tip. For difficult areas (between theteeth) use an lnterproximal Tooth Cleaning Brush or dental flosscoated with GC Tooth Mousse.

2. Leave GC Tooth Mousse on the teeth undisturbed for a minimum of3 minutes.

3. Then use your tongue to spread the remaining GC Tooth Moussethroughout the mouth. Hold in the mouth for as long as possible(a further 1 - 2 minutes) avoiding expectoration (spitting out) anddelaying swallowing. The longer GC Tooth Mousse and saliva aremaintained in the mouth, the more effective the result.

4. Expectorate thoroughly and if possible avoid rinsing. AnyGC Tooth Mousse remaining on the surface can be left to graduallydissipate overnight. Do not eat or drink for 30 minutes followingapplication.

FLAVORSStrawberry, Melon, Vanilla, Mint, Tutti-Frutti

STORAGERecommended for optimal performance, store in a cool dry low humidityarea away from direct sunlight (B-25"C; 46.4-77.0"F).

PACKAGESTube containing 409 (35mL)1. Assorted Package

10 x 409 (2 each of Strawberry, Melon, Vanilla, Mint, Tutti-Frutti)2. Single Flavor Package

10 x 409 in each flavorVanilla, Strawberry, Melon, Tutti-Frutti, Mint

3. Refill Package1 x 409 tube in each flavor

NOTEGC Tooth Mousse with its unique CPP-ACP formulation was developedat The School of Dental Science, The University of Melbourne VictoriaAustralia."RECALDENT is a trademark used under licence. CPP-ACP technologyhas related patents or patents pending in Australia, NZ, Europe,Canada, and USA.

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DrrawDerry, Meton, vantila, Mtnt, luttt_FruttiSTORAGERecommended for optimal performance, store in a cool dry low humidityarea away from direct sunlight (8-25"C; 46.4-Tl.O"F)PACKAGESTube containing 409 (35mL)1. Assorted Package

19 * alg Q each of Strawberry, Meton, Vaniila, Mint, Tutti-Frutti)2. Single Flavor Package

10 x 409 in each flavorVanilla, Strawberry, Melon, Tutti-Frutti, Mint

3. Refill Package1 x 409 tube in each flavor

NOTEGC Tooth Mousse with it^s unique cpp-Acp formulation was developedat rhe school of Dental science, The University of Melbourne VictoriaAustralia..RECALDENT is a trademark used under licence. cpp-ACp technologyhas related patents or patents pending in Australia, NZ, Europe,Canada, and USA.CAUTION1 . Always replace cap after use and remove any residual paste or

moisture around the tube neck or inside the 6ap.2.ln case of contact with eyes, flush immediately with water and seek

medical attention.3. ln case of spillage on clothes, wash off with water.4.lf any angioedema symptoms are experienced, this may indicate

sensitivity or allergy to the benzoate preservatives, or to some othercomponent of the product such as a flavoring agent. ln this event,discontinue the use of the product and refer to J physician.

some products referenced in the present IFU may be classified ashazardous according to GHS. Always familiarize yourself with theSafety Data Sheets available at:http : //www. gceu rope. com/

They can also be obtained from your supplier.

Last revised : 06/2018

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MANUFACTURED BY

GC AMERICA INC.3737 West 127th Street, Atsip, tL 60803 U.S.A.

DISTRIBUTED BY

GC AMERICA INC.3737 West 127th Street, Atsip, tL 60803 U.S.A.TEL: +1-708-597-0900

GC CORPORATION76-1 Hasunuma-cho, ltabashi-ku, Tokyo 174-85g5, Japan

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GC EURopE N.v.Researchpark Haasrode-Leuven 124O, lnterleuvenlaan 33,8-3001 Leuven, Belgium TEL: +32 16 74 1O OO

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