RESPONSIBLE PPE- wt ppe kit
Point One International, Ltd.
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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Family PPE Kit
Family PPE Kit
RESPONSIBLE PPE
wt ppe kit kit |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 81207-010 |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 81207-010-02 | 1 in 1 KIT; Type 0: Not a Combination Product | 03/26/2021 | 03/26/2021 |
|
| Quantity of Parts |
| Part # | Package Quantity | Total Product Quantity |
| Part 1 | 1 POUCH | 70 mL |
| Part 2 | 1 BOTTLE, SPRAY | 59 mL |
|
| Part 1 of 2 |
BAMBOO SANITIZING WIPES
isopropyl alcohol cloth |
|
| Product Information |
| Item Code (Source) | NDC: 75109-519 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) | ISOPROPYL ALCOHOL | 70 mL in 100 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
| ALOE VERA LEAF (UNII: ZY81Z83H0X) | |
|
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 75109-519-01 | 10 in 1 BAG | | |
| 1 | | 55 mL in 1 POUCH; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 02/01/2021 | |
|
| Part 2 of 2 |
HAND SANITIZER
benzalkonium chloride spray |
|
| Product Information |
| Item Code (Source) | NDC: 78522-100 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) | BENZALKONIUM CHLORIDE | 2 mg in 59 mL |
|
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|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 78522-100-00 | 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 02/01/2021 | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 03/26/2021 | 03/26/2021 |
|
| Labeler - Point One International, Ltd.
(150340206)
|