WL-AAI-ZT-P-1910- titanium dioxide, zinc oxide powder
Nanophase Technologies Corporation
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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WL-AAI-ZT-P-1910
WL-AAI-ZT-P-1910
WL-AAI-ZT-P-1910
titanium dioxide, zinc oxide powder |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 63931-1910 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) | TITANIUM DIOXIDE | 0.125 g in 1 g |
| ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) | ZINC OXIDE | 0.225 g in 1 g |
|
|
|
| Product Characteristics |
| Color | brown | Score | |
| Shape | | Size | |
| Flavor | | Imprint Code | |
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 63931-1910-1 | 10000 g in 1 BAG; Type 0: Not a Combination Product | 07/25/2023 | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part352 | 07/25/2023 | |
|
| Labeler - Nanophase Technologies Corporation
(623502044)
|
| Registrant - Nanophase Technologies Corporation (623502044) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| Nanophase Technologies Corporation | | 050383046 | api manufacture(63931-1910) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| Nanophase Technologies Corporation | | 623502044 | api manufacture(63931-1910) , manufacture(63931-1910) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| Nanophase Technologies Corporation | | 118812921 | manufacture(63931-1910) , pack(63931-1910) |