Application Nr Approved Date Route Status External Links
NDA021669 2005-04-25 None OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Directions Before Opening, Turn Package Over, Burst Solution Packet With Thumbs. Peel Lid To Open. Brush Teeth And Oral Cavity For Approximately One Minute. Instruct To Expectorate. Use Applicator Swab For Additional Cleansing As Needed. Discard After Use. Use Up To 4 Times Daily Or As Directed By A Dentist Or Doctor. Children Under 12 Yeras Of Age: Supervise Use. Children Under 3 Years Of Age: Consult A Dentist Or Doctor. Use A Bite Block When Performing Oral Care On Patients With Altered Levels Of Consciousness Or Those Who Cannot Comprehend Commands. Ensure Foam Is Intact After Use. If Not, Remove Any Particles From Oral Cavity.

All Formulated Excipients (8 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. Xylitol XYLITOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Potassium Sorbate POTASSIUM SORBATE Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
5. Polysorbate 20 POLYSORBATE 20 Unresolved
6. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
8. Saccharin Sodium SACCHARIN SODIUM Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE ZINC1531008

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