| NDC Code | 83778-012-01 |
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| Package Description | 6 mL in 1 BOTTLE (83778-012-01) |
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| Product NDC | 83778-012 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Teethwhitening Kit |
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| Non-Proprietary Name | Teethwhitening Kit |
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| Dosage Form | CREAM |
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| Usage | TOPICAL |
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| Start Marketing Date | 20241214 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M022 |
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| Manufacturer | Jiangxi Dentalbright Technology Co., Ltd. |
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| Substance Name | PHTHALIMIDOPEROXYCAPROIC ACID; POTASSIUM CITRATE; TRIBASIC CALCIUM PHOSPHATE |
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| Strength | 12; 3; 1 |
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| Strength Unit | g/100mL; g/100mL; g/100mL |
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| Pharmacy Classes | Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE] |
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