4287 FIRST AID KIT 		
					
 
4287 first aid kit kit | 
| Product Information | 
 
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 0498-4287 | 
 
 
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| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-4287-01 | 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 | 1 BOTTLE  | 118 mL | 
 
| Part 2 | 20 PACKET  | 10 g | 
 
| Part 3 | 50 POUCH  | 20 mL | 
 
| Part 4 | 50 PACKET  | 100  | 
 
 
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| Part 1 of 4 | 
 
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 | 
 
 
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| 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: 0498-0100-02 | 118 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 |  | 
 
 
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| Part 2 of 4 | 
 
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 | 
 
 
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| 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 |      | 
 
 
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| 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 3 of 4 | 
 
ALCOHOL WIPE 		
					
 
isopropyl alcohol swab | 
 
 
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| Product Information | 
 
| Item Code (Source) | NDC: 0498-0143 | 
 
| Route of Administration | TOPICAL | 
 
 
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| 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)  |   | 
 
 
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| 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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| Part 4 of 4 | 
 
AYPANAL NON-ASPIRIN 		
					
 
acetaminophen tablet | 
 
 
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| Product Information | 
 
| Item Code (Source) | NDC: 0498-2001 | 
 
| Route of Administration | ORAL | 
 
 
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| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| ACETAMINOPHEN (UNII: 362O9ITL9D)  (ACETAMINOPHEN - UNII:362O9ITL9D)  | ACETAMINOPHEN | 325 mg | 
 
 
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| Product Characteristics | 
 
| Color | white | Score | 2 pieces | 
 
| Shape | ROUND | Size | 10mm | 
 
| Flavor |  | Imprint Code | 
                                 
                                 circle;U
                               | 
 
| Contains |      | 
 
 
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| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 |  | 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 | 04/10/2012 |  | 
 
 
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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 |  | 
 
 
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