Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-5747 |
Trade Name | Dose Form | Strength | Identifier |
60:60 Rinse solution (Bubblegum flavour) | Mouthwash | . | |
Sponsor | Application date | Registration situation | Classification |
Ivoclar Vivadent Ltd P O Box 303011 North Harbour Auckland 0751 | 30/11/1995 | Approval lapsed Approval date: 17/4/1997 Notification date: 18/12/2014 | Pharmacy only |
Composition
Component | Ingredient | Manufacturer |
Solution A Sodium fluoride solution, mouthwash | Active | |
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, mouthwash | Active | |
Stannous fluoride 1.64% | Ozark-Mahoning Company 5101 West 21st Street Tulsa Oklahoma 74107 UNITED STATES OF AMERICA | |
Excipient | ||
Ethanol | ||
Glycerol | ||
Menthol |
Production
Manufacturing step | Manufacturer |
Manufacture of Final Dose Form | Pascal Company Inc 2929 NE Northrup Way Bellevue Washington 98004-1430 UNITED STATES OF AMERICA |
Packing | Pascal Company Inc 2929 NE Northrup Way Bellevue Washington 98004-1430 UNITED STATES OF AMERICA |
NZ Site of Product Release | No site specified |
Packaging
Package | Contents | Shelf Life |
Bottle, plastic, solution B metered pump dispenser | 1.89 L | 60 months from date of manufacture stored at or below 30°C |
Bottle, plastic, solution A metered pump dispenser | 1.89 L | 60 months from date of manufacture stored at or below 30°C |
Combination pack, 2 metered pump dispensers, 1 mixing vial | 1.89 L | 60 months from date of manufacture stored at or below 30°C |