Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-5762/4 |
Trade Name | Dose Form | Strength | Identifier |
60 Second Taste gel | Topical gel | 2.73% w/w | Orange Twist flavour |
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 |
topical gel | Active | |
Sodium fluoride 2.73%{relative} (2.88% with 6% manufacturers overage.) | ||
Excipient | ||
Carbomer 940 | ||
Deep orange.47450 | ||
Enhancer flavour 5916-57 | ||
Orange flavour (creamsicle) 51445-53 | ||
Phosphoric acid | ||
Purified water | ||
Quinoline yellow | ||
Saccharin sodium | ||
Sodium benzoate | ||
Vanilla flavour KE 21856 | ||
Zinc oxide |
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, 1x480ml | 480 mL | 60 months from date of manufacture stored at or below 30°C |