4232 FIRST AID KIT
4232 first aid kit kit |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 0498-4232 |
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 0498-4232-01 | 1 in 1 KIT; Type 0: Not a Combination Product | 10/18/2018 | |
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| Quantity of Parts |
| Part # | Package Quantity | Total Product Quantity |
| Part 1 | 4 BOTTLE | 120 mL |
| Part 2 | 125 PACKET | 250 |
| Part 3 | 10 AMPULE | 3 mL |
| Part 4 | 1 CAN | 85 g |
| Part 5 | 1 CAN | 85 g |
| Part 6 | 20 PACKET | 10 g |
| Part 7 | 50 POUCH | 20 mL |
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| Part 1 of 7 |
EYESALINE EMERGENCY EYEWASH
purified water liquid |
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| Product Information |
| Item Code (Source) | NDC: 0498-0100 |
| Route of Administration | OPHTHALMIC |
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| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) | WATER | 98.6 mL in 100 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) | |
| SODIUM CHLORIDE (UNII: 451W47IQ8X) | |
| SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) | |
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 0498-0100-01 | 30 mL in 1 BOTTLE; Type 0: Not a Combination Product | | |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part349 | 12/18/2018 | |
|
| Part 2 of 7 |
ASPIRIN
aspirin tablet |
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| Product Information |
| Item Code (Source) | NDC: 0498-0114 |
| Route of Administration | ORAL |
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| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) | ASPIRIN | 325 mg |
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| Product Characteristics |
| Color | white | Score | 2 pieces |
| Shape | ROUND | Size | 10mm |
| Flavor | | Imprint Code |
FR21
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| Contains | |
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 0498-0114-01 | 2 in 1 PACKET; Type 0: Not a Combination Product | | |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part343 | 09/18/2018 | |
|
| Part 3 of 7 |
AMMONIA INHALENT
ammonia inhalent inhalant |
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| Product Information |
| Item Code (Source) | NDC: 0498-3334 |
| Route of Administration | RESPIRATORY (INHALATION) |
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| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) | AMMONIA | 0.045 g in 0.3 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| ALCOHOL (UNII: 3K9958V90M) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 0498-3334-00 | 0.3 mL in 1 AMPULE; Type 0: Not a Combination Product | | |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | | 09/18/2018 | |
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| Part 4 of 7 |
FIRST AID ANTISEPTIC WATER SOLUBLE
benzethonium chloride, benzocaine spray |
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| Product Information |
| Item Code (Source) | NDC: 0498-0031 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) | BENZETHONIUM CHLORIDE | 0.2 g in 100 g |
| BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) | BENZOCAINE | 10 g in 100 g |
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 0498-0031-40 | 85 g in 1 CAN; Type 0: Not a Combination Product | | |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 09/19/2018 | |
|
| Part 5 of 7 |
BURN WATER SOLUBLE
benzocaine, benzethonium chloride, menthol spray |
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| Product Information |
| Item Code (Source) | NDC: 0498-0021 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) | BENZETHONIUM CHLORIDE | 0.2 g in 100 g |
| BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) | BENZOCAINE | 10 g in 100 g |
| MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) | MENTHOL | 0.33 g in 100 g |
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 0498-0021-40 | 85 g in 1 CAN; Type 0: Not a Combination Product | | |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part348 | 11/12/2018 | |
|
| Part 6 of 7 |
TRIPLE ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment |
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| Product Information |
| Item Code (Source) | NDC: 0498-0750 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) | POLYMYXIN B | 5000 [iU] in 1 g |
| BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) | BACITRACIN | 400 [iU] in 1 g |
| NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) | NEOMYCIN | 3.5 mg in 1 g |
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| Inactive Ingredients |
| Ingredient Name | Strength |
| PETROLATUM (UNII: 4T6H12BN9U) | |
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| Product Characteristics |
| Color | white | Score | |
| Shape | | Size | |
| Flavor | | Imprint Code | |
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 0498-0750-36 | 0.5 g in 1 PACKET; Type 0: Not a Combination Product | | |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part333B | 09/19/2018 | |
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| Part 7 of 7 |
ALCOHOL WIPE
isopropyl alcohol swab |
|
| Product Information |
| Item Code (Source) | NDC: 0498-0143 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) | ISOPROPYL ALCOHOL | 0.7 mL in 1 mL |
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| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 0498-0143-04 | 0.4 mL in 1 POUCH; Type 0: Not a Combination Product | | |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333A | 09/18/2018 | |
|
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | | 10/18/2018 | |
|