Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-5762/1 |
| Trade Name | Dose Form | Strength | Identifier |
| 60 Second Taste gel | Topical gel | 2.73% w/w | (Bubblegum 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: 21/9/2020 | Pharmacy only |
Composition
| Component | Ingredient | Manufacturer |
| topical gel | Active | |
| Sodium fluoride 2.73%{relative} (2.88%w/w with 6% manufacturers overage.) | ||
| Excipient | ||
| Carbomer 940 | ||
| Pascal red. | ||
| Flavour enhancer western. 5916-57 | ||
| Fruit mix flavour 53299-93 | ||
| Methyl salicylate | ||
| Phosphoric acid | ||
| Purified water | ||
| Saccharin sodium | ||
| Sodium benzoate | ||
| Vanilla flavour KE 21856 |
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 |
