CARE BUS AND CLASSROOM YELLOW
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, benzalkonium chloride, lidocaine hydrochloride, isopropyl alcohol, benzocaine, alcohol kit |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 49687-0025 |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 49687-0025-0 | 1 in 1 KIT | 02/13/2018 | |
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Quantity of Parts |
Part # | Package Quantity | Total Product Quantity |
Part 1 | 2 BAG | 1.8 g |
Part 2 | 2 PACKAGE | 1.8 g |
Part 3 | 2 BAG | 0.9 g |
Part 4 | 2 POUCH | 0.9 g |
Part 5 | 2 PACKAGE | 1 mL |
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Part 1 of 5 |
FIRST AID ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment |
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Product Information |
Item Code (Source) | NDC: 50814-007 |
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 |
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) | NEOMYCIN | 3.5 mg in 1 g |
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) | POLYMYXIN B | 5000 [iU] in 1 g |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | | 2 in 1 KIT | | |
1 | NDC: 50814-007-01 | 0.9 g in 1 BAG; 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 | 02/13/2018 | |
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Part 2 of 5 |
FIRST AID ANTISEPTIC PAIN RELIEVING
benzalkonium chloride, lidocaine hydrochloride cream |
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Product Information |
Item Code (Source) | NDC: 50814-009 |
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 g |
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) | LIDOCAINE HYDROCHLORIDE ANHYDROUS | 5 mg in 1 g |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | | 2 in 1 KIT | | |
1 | NDC: 50814-009-01 | 0.9 g in 1 PACKAGE; 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 | 02/13/2018 | |
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Part 3 of 5 |
ALCOHOL CLEANSING
isopropyl alcohol swab |
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Product Information |
Item Code (Source) | NDC: 50814-039 |
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 | 700 mg in 1 g |
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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 | | 2 in 1 KIT | | |
1 | NDC: 50814-039-01 | 1 in 1 BOX | | |
1 | | 0.45 g in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part333A | 02/13/2018 | |
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Part 4 of 5 |
ANTISEPTIC TOWELETTE
benzalkonium chloride swab |
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Product Information |
Item Code (Source) | NDC: 50814-002 |
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 | 0.13 g in 100 g |
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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 | | 2 in 1 KIT | | |
1 | NDC: 50814-002-01 | 1 in 1 BOX | | |
1 | | 0.45 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part333E | 02/13/2018 | |
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Part 5 of 5 |
INSECT STING RELIEF PAD
benzocaine,alcohol swab |
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Product Information |
Item Code (Source) | NDC: 52124-0008 |
Route of Administration | TOPICAL |
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Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) | BENZOCAINE | 0.6 mg in 100 mL |
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 60 mL in 100 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 | | 2 in 1 KIT | | |
1 | NDC: 52124-0008-1 | 0.5 mL in 1 PACKAGE; 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 | 02/13/2018 | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part348 | 02/13/2018 | |
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