4032 FIRST AID KIT 		
					
 
4032 first aid kit kit | 
| Product Information | 
 
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 0498-4032 | 
 
 
 | 
| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-4032-01 | 1  in 1 KIT; Type 0: Not a Combination Product | 10/18/2018 |  | 
 
 
 | 
| Quantity of Parts | 
 
| Part # | Package Quantity | Total Product Quantity | 
 
| Part 1 | 1 BOTTLE  | 30 mL | 
 
| Part 2 | 6 PACKET  | 8.4 mL | 
 
| Part 3 | 12 PACKET  | 24  | 
 
| Part 4 | 4 PACKET  | 3.6 g | 
 
| Part 5 | 2 AMPULE  | 0.6 mL | 
 
| Part 6 | 1 BOTTLE  | 59 mL | 
 
 
 | 
| Part 1 of 6 | 
 
EYESALINE EMERGENCY EYEWASH 		
					
 
purified water liquid | 
 
 
 | 
| Product Information | 
 
| Item Code (Source) | NDC: 0498-0100 | 
 
| Route of Administration | OPHTHALMIC | 
 
 
 | 
| 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)  |   | 
 
 
 | 
 | 
| 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 |  |  | 
 
 
 | 
 | 
| 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 6 | 
 
ANTISEPTIC TOWELETTE 		
					
 
benzalkonium chloride liquid | 
 
 
 | 
| Product Information | 
 
| Item Code (Source) | NDC: 0498-0501 | 
 
| Route of Administration | TOPICAL | 
 
 
 | 
| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  (BENZALKONIUM - UNII:7N6JUD5X6Y)  | BENZALKONIUM CHLORIDE | 1.3 mg  in 1 mL | 
 
 
 | 
| Inactive Ingredients | 
 
| Ingredient Name | Strength | 
 
| WATER (UNII: 059QF0KO0R)  |   | 
 
 
 | 
 | 
| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-0501-00 | 1.4 mL in 1 PACKET; 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 | 12/21/2017 |  | 
 
 
 | 
| Part 3 of 6 | 
 
ASPIRIN 		
					
 
aspirin tablet | 
 
 
 | 
| Product Information | 
 
| Item Code (Source) | NDC: 0498-0114 | 
 
| Route of Administration | ORAL | 
 
 
 | 
| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| ASPIRIN (UNII: R16CO5Y76E)  (ASPIRIN - UNII:R16CO5Y76E)  | ASPIRIN | 325 mg | 
 
 
 | 
| 
 | 
| Product Characteristics | 
 
| Color | white | Score | 2 pieces | 
 
| Shape | ROUND | Size | 10mm | 
 
| Flavor |  | Imprint Code | 
                                 
                                 FR21
                               | 
 
| Contains |      | 
 
 
 | 
| 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 |  |  | 
 
 
 | 
 | 
| Marketing Information | 
 
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | 
 
| OTC monograph not final | part343 | 09/18/2018 |  | 
 
 
 | 
| Part 4 of 6 | 
 
TRIPLE ANTIBIOTIC 		
					
 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment | 
 
 
 | 
| Product Information | 
 
| Item Code (Source) | NDC: 0498-0750 | 
 
| Route of Administration | TOPICAL | 
 
 
 | 
| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| BACITRACIN ZINC (UNII: 89Y4M234ES)  (BACITRACIN - UNII:58H6RWO52I)  | BACITRACIN | 400 [iU]  in 1 g | 
 
| POLYMYXIN B SULFATE (UNII: 19371312D4)  (POLYMYXIN B - UNII:J2VZ07J96K)  | POLYMYXIN B | 5000 [iU]  in 1 g | 
 
| NEOMYCIN SULFATE (UNII: 057Y626693)  (NEOMYCIN - UNII:I16QD7X297)  | NEOMYCIN | 3.5 mg  in 1 g | 
 
 
 | 
| Inactive Ingredients | 
 
| Ingredient Name | Strength | 
 
| PETROLATUM (UNII: 4T6H12BN9U)  |   | 
 
 
 | 
| Product Characteristics | 
 
| Color | white | Score |      | 
 
| Shape |  | Size |  | 
 
| Flavor |  | Imprint Code |  | 
 
| Contains |      | 
 
 
 | 
| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-0750-35 | 0.9 g in 1 PACKET; Type 0: Not a Combination Product |  |  | 
 
 
 | 
 | 
| Marketing Information | 
 
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | 
 
| OTC monograph final | part333B | 09/19/2018 |  | 
 
 
 | 
| Part 5 of 6 | 
 
AMMONIA INHALENT 		
					
 
ammonia inhalent inhalant | 
 
 
 | 
| Product Information | 
 
| Item Code (Source) | NDC: 0498-3334 | 
 
| Route of Administration | RESPIRATORY (INHALATION) | 
 
 
 | 
| 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 |  |  | 
 
 
 | 
 | 
| Marketing Information | 
 
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | 
 
| unapproved drug other |  | 09/18/2018 |  | 
 
 
 | 
| Part 6 of 6 | 
 
BURN RELIEF 		
					
 
lidocaine hydrochloride spray | 
 
 
 | 
| Product Information | 
 
| Item Code (Source) | NDC: 0498-0221 | 
 
| Route of Administration | TOPICAL | 
 
 
 | 
| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A)  (LIDOCAINE - UNII:98PI200987)  | LIDOCAINE HYDROCHLORIDE ANHYDROUS | 24.64 mg  in 1 mL | 
 
 
 | 
| 
 | 
 | 
| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-0221-59 | 59 mL in 1 BOTTLE; 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 | part348 | 09/18/2018 |  | 
 
 
 | 
 | 
| Marketing Information | 
 
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | 
 
| unapproved drug other |  | 10/18/2018 |  | 
 
 
 |