10 PERSON ANSI
benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, water, benzocaine, alcohol, ibuprofen, acetaminophen, aspirin kit |
Product Information |
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 52124-0111 |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 52124-0111-1 | 1 in 1 KIT | | |
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Quantity of Parts |
Part # | Package Quantity | Total Product Quantity |
Part 1 | 6 PACKAGE | 5.4 g |
Part 2 | 10 PACKAGE | 8 mL |
Part 3 | 6 TUBE | 3 g |
Part 4 | 1 BOTTLE | 10 mL |
Part 5 | 1 PACKAGE | 0.5 mL |
Part 6 | 1 PACKAGE | 2 |
Part 7 | 1 PACKAGE | 2 |
Part 8 | 1 PACKAGE | 2 |
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Part 1 of 8 |
GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE
benzalkonium chloride, lidocaine cream |
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Product Information |
Item Code (Source) | NDC: 52124-0004 |
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 |
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) | LIDOCAINE | 0.5 in 100 g |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 52124-0004-1 | 0.9 g in 1 PACKAGE | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part345 | 04/24/2010 | |
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Part 2 of 8 |
ANTISEPTIC TOWELETTE
benzalkonium chloride liquid |
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Product Information |
Item Code (Source) | NDC: 52124-0001 |
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 | 0.40 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 | NDC: 52124-0001-1 | 0.8 mL in 1 PACKAGE | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part333 | 04/24/2010 | |
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Part 3 of 8 |
GENUINE TRIPLE ANTIBIOTIC
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment |
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Product Information |
Item Code (Source) | NDC: 52124-0003 |
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 ZINC | 400 [iU] in 1 g |
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) | NEOMYCIN SULFATE | 5 mg in 1 g |
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) | POLYMYXIN B SULFATE | 5000 [iU] in 1 g |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 52124-0003-1 | 0.5 g in 1 TUBE | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part333 | 04/24/2010 | |
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Part 4 of 8 |
STERILE ISOTONIC BUFFERED GENUINE EYEWASH
water liquid |
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Product Information |
Item Code (Source) | NDC: 52124-0005 |
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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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 52124-0005-1 | 10 mL in 1 BOTTLE | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part349 | 04/24/2010 | |
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Part 5 of 8 |
INSECT STING RELIEF PAD
benzocaine,alcohol liquid |
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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 | 6 mL in 100 mL |
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 60 mL in 100 mL |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 52124-0008-1 | 0.5 mL in 1 PACKAGE | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part348 | 04/24/2010 | |
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Part 6 of 8 |
IBUPROFEN
ibuprofen tablet |
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Product Information |
Item Code (Source) | NDC: 52124-0009 |
Route of Administration | ORAL |
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Active Ingredient/Active Moiety |
Ingredient Name | Basis of Strength | Strength |
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) | IBUPROFEN | 200 mg |
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Product Characteristics |
Color | white (White) | Score | no score |
Shape | ROUND | Size | 10mm |
Flavor | | Imprint Code |
44;352
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Contains | |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 52124-0009-1 | 2 in 1 PACKAGE | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA075010 | 04/24/2010 | |
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Part 7 of 8 |
NON-ASPIRIN
acetaminophen tablet |
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Product Information |
Item Code (Source) | NDC: 52124-0010 |
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 (WHITE) | Score | no score |
Shape | ROUND | Size | 11mm |
Flavor | | Imprint Code |
AZ;234
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Contains | |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 52124-0010-1 | 2 in 1 PACKAGE | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part343 | 04/24/2010 | |
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Part 8 of 8 |
ASPIRIN
aspirin tablet |
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Product Information |
Item Code (Source) | NDC: 52124-0011 |
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 (White) | Score | no score |
Shape | ROUND | Size | 11mm |
Flavor | | Imprint Code |
44;157;ASPIRIN
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Contains | |
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Packaging |
# | Item Code | Package Description | Marketing Start Date | Marketing End Date |
1 | NDC: 52124-0011-1 | 2 in 1 PACKAGE | | |
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Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part343 | 04/24/2010 | |
|
|
Marketing Information |
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part333 | 04/24/2010 | |
|