4246 FIRST AID KIT 		
					
 
4246 first aid kit kit | 
| Product Information | 
 
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 0498-4246 | 
 
 
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| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-4246-01 | 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 | 2 TUBE  | 28 g | 
 
| Part 2 | 10 PACKET  | 9 g | 
 
| Part 3 | 2 BOTTLE  | 60 mL | 
 
| Part 4 | 50 PACKET  | 100  | 
 
| Part 5 | 10 AMPULE  | 3 mL | 
 
| Part 6 | 2 BOTTLE, SPRAY  | 118 mL | 
 
| Part 7 | 10 POUCH  | 4 mL | 
 
| Part 8 | 100 POUCH  | 30 mL | 
 
| Part 9 | 6 PACKET  | 21 g | 
 
| Part 10 | 10 PACKET  | 9 g | 
 
| Part 11 | 25 PACKET  | 50  | 
 
 
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| Part 1 of 11 | 
 
BLISTEX 		
					FOILLE MEDICATED FIRST AID
 
benzocaine and chloroxylenol ointment | 
 
 
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| Product Information | 
 
| Item Code (Source) | NDC: 10157-9302 | 
 
| Route of Administration | TOPICAL | 
 
 
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| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| CHLOROXYLENOL (UNII: 0F32U78V2Q)  (CHLOROXYLENOL - UNII:0F32U78V2Q)  | CHLOROXYLENOL | 0.1 g  in 100 g | 
 
| BENZOCAINE (UNII: U3RSY48JW5)  (BENZOCAINE - UNII:U3RSY48JW5)  | BENZOCAINE | 5 g  in 100 g | 
 
 
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| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 |  | 14 g in 1 TUBE; 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 | 03/05/2013 |  | 
 
 
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| Part 2 of 11 | 
 
HYDROCORTISONE 		
					
 
anti-itch cream | 
 
 
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| Product Information | 
 
| Item Code (Source) | NDC: 0498-0801 | 
 
| Route of Administration | TOPICAL | 
 
 
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| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| HYDROCORTISONE ACETATE (UNII: 3X7931PO74)  (HYDROCORTISONE - UNII:WI4X0X7BPJ)  | HYDROCORTISONE ACETATE | 1 g  in 100 g | 
 
 
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| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-0801-35 | 0.9 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 not final | part348 | 10/15/2019 |  | 
 
 
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| Part 3 of 11 | 
 
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: 0498-0100-01 | 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 |  | 
 
 
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| Part 4 of 11 | 
 
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
                               | 
 
| 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 |  | 
 
 
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| Part 5 of 11 | 
 
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 | 
 
 
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| Inactive Ingredients | 
 
| Ingredient Name | Strength | 
 
| ALCOHOL (UNII: 3K9958V90M)  |   | 
 
 
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| 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 6 of 11 | 
 
BURN RELIEF 		
					
 
lidocaine hydrochloride spray | 
 
 
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| Product Information | 
 
| Item Code (Source) | NDC: 0498-0221 | 
 
| Route of Administration | TOPICAL | 
 
 
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| 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 | 
 
 
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| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-0221-59 | 59 mL in 1 BOTTLE, SPRAY; 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 | 09/18/2018 |  | 
 
 
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| Part 7 of 11 | 
 
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 8 of 11 | 
 
PVP IODINE WIPE 		
					
 
povidone-iodine 10% swab | 
 
 
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| Product Information | 
 
| Item Code (Source) | NDC: 0498-0121 | 
 
| Route of Administration | TOPICAL | 
 
 
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| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| POVIDONE-IODINE (UNII: 85H0HZU99M)  (IODINE - UNII:9679TC07X4)  | IODINE | 10 mg  in 1 mL | 
 
 
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| Inactive Ingredients | 
 
| Ingredient Name | Strength | 
 
| NONOXYNOL-9 (UNII: 48Q180SH9T)  |   | 
 
| WATER (UNII: 059QF0KO0R)  |   | 
 
 
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| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-0121-00 | 0.3 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 | 
 
| unapproved drug other |  | 09/18/2018 |  | 
 
 
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| Part 9 of 11 | 
 
BURN JEL 		
					
 
gel for burns gel | 
 
 
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| Product Information | 
 
| Item Code (Source) | NDC: 0498-0203 | 
 
| Route of Administration | TOPICAL | 
 
 
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| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A)  (LIDOCAINE - UNII:98PI200987)  | LIDOCAINE HYDROCHLORIDE ANHYDROUS | 2 g  in 100 g | 
 
 
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| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-0203-00 | 3.5 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 not final | part348 | 09/18/2018 |  | 
 
 
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| Part 10 of 11 | 
 
HYDROCORTISONE 		
					
 
anti-itch cream ointment | 
 
 
 | 
| Product Information | 
 
| Item Code (Source) | NDC: 0498-0800 | 
 
| Route of Administration | TOPICAL | 
 
 
 | 
| Active Ingredient/Active Moiety | 
 
| Ingredient Name | Basis of Strength | Strength | 
 
| HYDROCORTISONE ACETATE (UNII: 3X7931PO74)  (HYDROCORTISONE - UNII:WI4X0X7BPJ)  | HYDROCORTISONE ACETATE | 1 g  in 100 g | 
 
 
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| 
 | 
 | 
| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-0800-35 | 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 not final | part348 | 03/06/2013 | 10/15/2019 | 
 
 
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| Part 11 of 11 | 
 
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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| 
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| Product Characteristics | 
 
| Color | white | Score | 2 pieces | 
 
| Shape | ROUND | Size | 10mm | 
 
| Flavor |  | Imprint Code | 
                                 
                                 circle;U
                               | 
 
| Contains |      | 
 
 
 | 
| Packaging | 
 
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date | 
 
| 1 | NDC: 0498-2001-01 | 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 | 01/02/2017 |  | 
 
 
 | 
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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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