Application Nr Approved Date Route Status External Links
NDA020231 1997-07-11 Dental OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Active Ingredients Purpose Sodium Fluoride 0.24% (0.14% W/v Fluoride Ion) Anticavity Triclosan 0.30% Antigingivitis

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Water WATER Molecular
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Pvm/ma Copolymer PVM/MA COPOLYMER Unresolved
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
6. Carboxymethylcellulose Sodium, Unspecified Form CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM Unresolved
7. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. Carrageenan CARRAGEENAN Unresolved
10. Saccharin Sodium SACCHARIN SODIUM Molecular
11. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
12. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Sodium Fluoride
2. Triclosan TRICLOSAN ZINC2216

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