Application Nr Approved Date Route Status External Links
NDA020802 1998-01-14 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Pain Reliever Pain Reliever Pain Reliever Aid

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Benzoic Acid BENZOIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
2. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Light Mineral Oil LIGHT MINERAL OIL Unresolved
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polysorbate 20 POLYSORBATE 20 Unresolved
7. Povidones POVIDONES Unresolved
8. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. Simethicone Emulsion SIMETHICONE EMULSION Unresolved
10. Sorbitan Monolaurate SORBITAN MONOLAURATE Molecular
11. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
12. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 3 Total)

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