GFA FIRST AID
75 PERSON METAL CASE
benzalkonium chloride, benzalkonium chloride, lidocaine, bacitracin zinc,neomycin sulfate,polymyxin b sulfate, povidone-iodine, water, alcohol, aspirin, ibuprofen, acetaminophen, benzocaine, alcohol kit |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 52124-1154 |
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-1154-1 | 1 in 1 KIT | | |
|
| Quantity of Parts |
| Part # | Package Quantity | Total Product Quantity |
| Part 1 | 50 PACKAGE | 40.0 mL |
| Part 2 | 12 PACKET | 10.8 g |
| Part 3 | 10 TUBE | 5.0 g |
| Part 4 | 10 PACKET | 5 mL |
| Part 5 | 2 BOTTLE | 20 mL |
| Part 6 | 5 PACKET | 4.5 g |
| Part 7 | 30 PACKAGE | 15 mL |
| Part 8 | 12 PACKAGE | 6 mL |
| Part 9 | 2 PACKET | 4 |
| Part 10 | 2 PACKAGE | 4 |
| Part 11 | 4 PACKAGE | 8 |
|
| Part 1 of 11 |
ANTISEPTIC TOWELETTE
benzalkonium chloride swab |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0001 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) | BENZALKONIUM CHLORIDE | 0.4 mL in 100 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-0001-1 | 0.8 mL in 1 PACKAGE | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 05/03/2011 | |
|
| Part 2 of 11 |
GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE
benzalkonium chloride, lidocaine cream |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0004 |
| Route of Administration | TOPICAL |
|
| 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 g 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 PACKET | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part333A | 04/13/2011 | |
|
| Part 3 of 11 |
GENUINE TRIPLE ANTIBIOTIC
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0003 |
| Route of Administration | TOPICAL |
|
| 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 |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-0003-1 | 0.5 g in 1 TUBE | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part333B | 04/13/2011 | |
|
| Part 4 of 11 |
POVIDONE-IODINE PREP
povidone-iodine swab |
|
| Product Information |
| Item Code (Source) | NDC: 52124-2901 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) | IODINE | 1 mL in 100 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-2901-0 | 0.5 mL in 1 PACKET | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 05/03/2011 | |
|
| Part 5 of 11 |
STERILE ISOTONIC BUFFERED GENUINE EYEWASH
water liquid |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0005 |
| Route of Administration | OPHTHALMIC |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) | WATER | 98.16 mL in 100 mL |
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|
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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 | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part349 | 05/04/2011 | |
|
| Part 6 of 11 |
GENUINE HAND SANITIZER
alcohol gel |
|
| Product Information |
| Item Code (Source) | NDC: 52124-2906 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 62 g in 100 g |
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|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-2906-1 | 0.9 g in 1 PACKET | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333A | 03/28/2011 | |
|
| Part 7 of 11 |
ALCOHOL CLEANSING PAD
isopropyl alcohol liquid |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0002 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) | ISOPROPYL ALCOHOL | 70 mL in 100 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-0002-1 | 0.5 mL in 1 PACKAGE | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333A | 04/23/2010 | |
|
| Part 8 of 11 |
INSECT STING RELIEF PAD
benzocaine,alcohol swab |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0008 |
| Route of Administration | TOPICAL |
|
| 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 |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-0008-1 | 0.5 mL in 1 PACKAGE | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part348 | 04/23/2011 | |
|
| Part 9 of 11 |
IBUPROFEN
ibuprofen tablet |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0009 |
| Route of Administration | ORAL |
|
| 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 | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-0009-1 | 2 in 1 PACKET | | |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075010 | 02/17/2010 | |
|
| Part 10 of 11 |
NON-ASPIRIN
acetaminophen tablet |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0010 |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) | ACETAMINOPHEN | 325 mg |
|
|
|
| Product Characteristics |
| Color | white (White) | Score | no score |
| Shape | ROUND | Size | 11mm |
| Flavor | | Imprint Code |
AZ;234
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-0010-1 | 2 in 1 PACKAGE | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part343 | 04/23/2010 | |
|
| Part 11 of 11 |
ASPIRIN
aspirin tablet |
|
| Product Information |
| Item Code (Source) | NDC: 52124-0011 |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) | ASPIRIN | 325 mg |
|
|
|
| Product Characteristics |
| Color | white (White) | Score | no score |
| Shape | ROUND | Size | 11mm |
| Flavor | | Imprint Code |
44;157;ASPIRIN
|
| Contains | |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 52124-0011-1 | 2 in 1 PACKAGE | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part343 | 04/23/2010 | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part333E | 05/03/2011 | |
|