Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-5747
Trade NameDose FormStrengthIdentifier
60:60 Rinse solution (Bubblegum flavour)Mouthwash.
SponsorApplication dateRegistration situationClassification
Ivoclar Vivadent Ltd
P O Box 303011
North Harbour
Auckland 0751
30/11/1995Approval lapsed
Approval date: 17/4/1997
Notification date: 18/12/2014
Pharmacy only
 

Composition

ComponentIngredientManufacturer
Solution A Sodium fluoride solution, mouthwashActive 
 Sodium fluoride 0.685%Norman Lauder
Dundrum
Dublin
IRELAND
 Excipient 
 Acid red 33
 Brilliant blue FCF
 Dibasic sodium phosphate
 Ethanol
 Phosphoric acid
 Poloxamer
 Purified water
 Quinoline yellow
 Saccharin
solution B Stannous fluoride solution, mouthwashActive 
 Stannous fluoride 1.64%Ozark-Mahoning Company
5101 West 21st Street
Tulsa
Oklahoma 74107
UNITED STATES OF AMERICA
 Excipient 
 Ethanol
 Glycerol
 Menthol

Production

Manufacturing stepManufacturer
Manufacture of Final Dose FormPascal Company Inc
2929 NE Northrup Way
Bellevue
Washington 98004-1430
UNITED STATES OF AMERICA
PackingPascal Company Inc
2929 NE Northrup Way
Bellevue
Washington 98004-1430
UNITED STATES OF AMERICA
NZ Site of Product ReleaseNo site specified

Packaging

PackageContentsShelf Life
Bottle, plastic, solution B metered pump dispenser1.89 L60 months from date of manufacture stored at or below 30°C
Bottle, plastic, solution A metered pump dispenser1.89 L60 months from date of manufacture stored at or below 30°C
Combination pack, 2 metered pump dispensers, 1 mixing vial1.89 L60 months from date of manufacture stored at or below 30°C
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