4248 FIRST AID KIT
4248 first aid kit kit |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 0498-4248 |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 0498-4248-01 | 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 BOTTLE | 236 mL |
Part 2 | 10 AMPULE | 3 mL |
Part 3 | 1 CAN | 85 g |
Part 4 | 1 CAN | 85 g |
Part 5 | 20 PACKET | 10 g |
Part 6 | 50 POUCH | 20 mL |
Part 7 | 125 PACKET | 250 |
Part 8 | 20 PACKET | 28 mL |
Part 9 | 125 PACKET | 250 |
Part 10 | 30 PACKET | 27 g |
Part 11 | 10 POUCH | 4 mL |
Part 12 | 125 PACKET | 250 |
Part 13 | 50 PACKET | 100 |
Part 14 | 1 BOTTLE, DROPPER | 15 mL |
Part 15 | 30 PACKET | 27 g |
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Part 1 of 15 |
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: 0498-0100-02 | 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 15 |
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 3 of 15 |
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 | |
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Part 4 of 15 |
BURN WATER SOLUBLE
benzocaine, benzethonium chloride, menthol spray |
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Product Information |
Item Code (Source) | NDC: 0498-0021 |
Route of Administration | TOPICAL |
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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 | |
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Part 5 of 15 |
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 6 of 15 |
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) | |
|
|
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 7 of 15 |
MIRALAC
calcium carbonate tablet |
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Product Information |
Item Code (Source) | NDC: 0498-0303 |
Route of Administration | ORAL |
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Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) | CALCIUM CARBONATE | 420 mg |
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Product Characteristics |
Color | white | Score | 2 pieces |
Shape | ROUND | Size | 11mm |
Flavor | MINT | Imprint Code |
FR8
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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 final | part331 | 02/22/2012 | |
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Part 8 of 15 |
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 15 |
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
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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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Part 10 of 15 |
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 11 of 15 |
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 12 of 15 |
PAIN STOPPERS
acetaminophen, caffeine, aspirin, salicylamide tablet |
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Product Information |
Item Code (Source) | NDC: 0498-2422 |
Route of Administration | ORAL |
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Product Characteristics |
Color | orange (BRIGHT ORANGE) | Score | no score |
Shape | ROUND | Size | 11mm |
Flavor | | Imprint Code |
FR;2
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Contains | |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 0498-2422-01 | 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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Part 13 of 15 |
SINUS DECONGESTANT
phenylephrine tablet |
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Product Information |
Item Code (Source) | NDC: 0498-3331 |
Route of Administration | ORAL |
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Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) | PHENYLEPHRINE HYDROCHLORIDE | 5 mg |
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Product Characteristics |
Color | red | Score | no score |
Shape | OVAL | Size | 11mm |
Flavor | | Imprint Code |
FR4
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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 final | part341 | 09/18/2018 | |
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Part 14 of 15 |
EYE DROPS
tetrahydrozoline hydrochloride solution/ drops |
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Product Information |
Item Code (Source) | NDC: 0498-0161 |
Route of Administration | OPHTHALMIC |
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Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) | TETRAHYDROZOLINE HYDROCHLORIDE | 0.05 g in 100 mL |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | | 15 mL in 1 BOTTLE, DROPPER; 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 | 07/04/2018 | |
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Part 15 of 15 |
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 | | |
|
|
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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