Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-5747/2 |
Trade Name | Dose Form | Strength | Identifier |
60:60 Rinse solution (Raspberry 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: 23/2/2009 | Pharmacy only |
Composition
Component | Ingredient | Manufacturer |
Combintion pack Soln A and Soln B Use 4 parts A : 1 part B, mouthwash | Active | |
Sodium fluoride 0.685% | Norman Lauder Dundrum Dublin IRELAND | |
Stannous fluoride 1.64% | Ozark-Mahoning Company 5101 West 21st Street Tulsa Oklahoma 74107 UNITED STATES OF AMERICA | |
Solution A Sodium fluoride 0.685%, mouthwash | Sodium fluoride 0.685% | |
Excipient | ||
Acid red 33 | ||
Dibasic sodium phosphate | ||
Phosphoric acid | ||
Poloxamer | ||
Purified water | ||
Raspberry | ||
Saccharin sodium | ||
Solution B Stannous Fluoride 1.64%, mouthwash | Active | |
Stannous fluoride 1.64% | ||
Excipient | ||
Glycerol |
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, Bottle Soln B | 1.89 L | 60 months from date of manufacture stored at or below 30°C |
Bottle, plastic, bottle soln A + mixing vial | 1.89 L | 60 months from date of manufacture stored at or below 30°C |