4365 FIRST AID KIT
4365 first aid kit kit |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 0498-4365 |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 0498-4365-01 | 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 | 125 PACKET | 250 |
Part 3 | 10 AMPULE | 3 mL |
Part 4 | 1 BOTTLE, SPRAY | 59 mL |
Part 5 | 10 POUCH | 4 mL |
Part 6 | 10 POUCH | 3 mL |
Part 7 | 10 PACKET | 9 g |
Part 8 | 20 PACKET | 28 mL |
Part 9 | 20 PACKET | 10 g |
Part 10 | 10 POUCH | 4 mL |
Part 11 | 10 PACKET | 9 g |
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Part 1 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: 0498-0100-02 | 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 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
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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 | |
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Part 3 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 4 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 5 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 6 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 7 of 11 |
HYDROCORTISONE
anti-itch cream ointment |
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Product Information |
Item Code (Source) | NDC: 0498-0800 |
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: 0498-0800-35 | 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 | 03/06/2013 | 10/15/2019 |
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Part 8 of 11 |
ANTISEPTIC TOWELETTE
benzalkonium chloride liquid |
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Product Information |
Item Code (Source) | NDC: 0498-0501 |
Route of Administration | TOPICAL |
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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 |
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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: 0498-0501-00 | 1.4 mL 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 | part333E | 12/22/2017 | |
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Part 9 of 11 |
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 |
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 |
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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 10 of 11 |
STING RELIEF PAD
ethyl alcohol, lidocaine swab |
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Product Information |
Item Code (Source) | NDC: 0498-0733 |
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 | 20 mg in 1 mL |
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 0.5 mL in 1 mL |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 0498-0733-00 | 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 | part348 | 12/23/2017 | |
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Part 11 of 11 |
HYDROCORTISONE
anti-itch cream |
|
Product Information |
Item Code (Source) | NDC: 0498-0801 |
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: 0498-0801-35 | 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 | 10/15/2019 | |
|
|
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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