WL-AAB-Z-W-1019- zinc oxide lotion
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-AAB-Z-W-1019
WL-AAB-Z-W-1019 GHS Label
WL-AAB-Z-W-1019
zinc oxide lotion |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 63931-4446 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) | ZINC OXIDE | 135.6 mg in 1 mL |
|
|
|
| Product Characteristics |
| Color | brown | Score | |
| Shape | | Size | |
| Flavor | | Imprint Code | |
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 63931-4446-1 | 150000 mL in 1 DRUM; Type 0: Not a Combination Product | 05/17/2021 | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part352 | 05/17/2021 | |
|
| Labeler - Nanophase Technologies Corporation
(623502044)
|
| Registrant - Nanophase Technologies Corporation (623502044) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| Nanophase Technologies Corporation | | 050383046 | api manufacture(63931-4446) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| Nanophase Technologies Corporation | | 623502044 | api manufacture(63931-4446) , manufacture(63931-4446) , pack(63931-4446) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| Amcol Health & Beauty Solutions | | 872684803 | api manufacture(63931-4446) |