ADVENTURE MEDICAL KITS 1-4 PERSON FIRST AIDÂ
benzalkonium chloride, aspirin, ibuprofen, isopropyl alcohol, benzocaine, sd alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen, diphenhydramine chloride kit |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC:44224-3000 |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC:44224-3000-1 | 1 in 1 KIT | | |
|
| Quantity of Parts |
| Part # | Package Quantity | Total Product Quantity |
| Part 1 | 4 TUBE | 2Â g |
| Part 2 | 2 PACKAGE | 1Â mL |
| Part 3 | 6 PACKET | 12Â |
| Part 4 | 6 PACKET | 6Â |
| Part 5 | 3 PACKET | 6Â |
| Part 6 | 4 PACKAGE | 8Â |
| Part 7 | 12 PACKAGE | 9.6Â mL |
|
| Part 1 of 7 |
GENUINE TRIPLE ANTIBIOTICÂ
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) | Â |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC:52124-0003-1 | .5 g in 1 TUBE | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part333B | 08/26/2010 | |
|
| Part 2 of 7 |
INSECT STING RELIEF PADÂ
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) | Â |
|
|
| 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 | 08/26/2010 | |
|
| Part 3 of 7 |
IBUPROFENÂ
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 | 200Â mg |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| POWDERED CELLULOSE (UNII: SMD1X3XO9M) | Â |
| STARCH, CORN (UNII: O8232NY3SJ) | Â |
| HYPROMELLOSES (UNII: 3NXW29V3WO) | Â |
| LACTOSE (UNII: J2B2A4N98G) | Â |
| MAGNESIUM STEARATE (UNII: 70097M6I30) | Â |
| POLYDEXTROSE (UNII: VH2XOU12IE) | Â |
| POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) | Â |
| POVIDONE (UNII: FZ989GH94E) | Â |
| SILICON DIOXIDE (UNII: ETJ7Z6XBU4) | Â |
| STEARIC ACID (UNII: 4ELV7Z65AP) | Â |
| TITANIUM DIOXIDE (UNII: 15FIX9V2JP) | Â |
| TRIACETIN (UNII: XHX3C3X673) | Â |
|
| Product Characteristics |
| Color | white (WHITE) | Score | no score |
| Shape | ROUND | Size | 10mm |
| Flavor | | Imprint Code |
44;352
|
| Contains | Â Â Â Â |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC:52124-0009-1 | 2 in 1 PACKET | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075010 | 08/26/2010 | |
|
| Part 4 of 7 |
MEDIQUE DIPHENÂ
diphenhydramine hydrochloride capsule |
|
| Product Information |
| Item Code (Source) | NDC:47682-182 |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) | DIPHENHYDRAMINE HYDROCHLORIDE | 25Â mg |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| GELATIN (UNII: 2G86QN327L) | Â |
| D&C RED NO. 28 (UNII: 767IP0Y5NH) | Â |
| FD&C BLUE NO. 1 (UNII: H3R47K3TBD) | Â |
| FD&C RED NO. 40 (UNII: WZB9127XOA) | Â |
| STARCH, CORN (UNII: O8232NY3SJ) | Â |
|
| Product Characteristics |
| Color | pink (PINK) , white (WHITE) | Score | no score |
| Shape | CAPSULE | Size | 14mm |
| Flavor | | Imprint Code |
CPC;835
|
| Contains | Â Â Â Â |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC:47682-182-46 | 1 in 1 PACKET | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 08/25/2010 | |
|
| Part 5 of 7 |
MEDIQUE APAP EXTRA STRENGTHÂ
acetaminophen tablet, film coated |
|
| Product Information |
| Item Code (Source) | NDC:47682-175 |
| Route of Administration | ORAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) | ACETAMINOPHEN | 500Â mg |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| CROSPOVIDONE (UNII: 68401960MK) | Â |
| HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) | Â |
| HYPROMELLOSES (UNII: 3NXW29V3WO) | Â |
| MAGNESIUM STEARATE (UNII: 70097M6I30) | Â |
| CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) | Â |
| MINERAL OIL (UNII: T5L8T28FGP) | Â |
| POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) | Â |
| POVIDONE (UNII: FZ989GH94E) | Â |
| PROPYLENE GLYCOL (UNII: 6DC9Q167V3) | Â |
| SILICON DIOXIDE (UNII: ETJ7Z6XBU4) | Â |
| CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) | Â |
| STEARIC ACID (UNII: 4ELV7Z65AP) | Â |
| TALC (UNII: 7SEV7J4R1U) | Â |
| TITANIUM DIOXIDE (UNII: 15FIX9V2JP) | Â |
| TRIACETIN (UNII: XHX3C3X673) | Â |
|
| Product Characteristics |
| Color | white (WHITE) | Score | no score |
| Shape | ROUND | Size | 12mm |
| Flavor | | Imprint Code |
AZ;235
|
| Contains | Â Â Â Â |
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC:47682-175-46 | 2 in 1 PACKET | | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part343 | 08/26/2010 | |
|
| Part 6 of 7 |
ASPIRINÂ
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 | 325Â mg |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| HYPROMELLOSES (UNII: 3NXW29V3WO) | Â |
| POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) | Â |
| PROPYLENE GLYCOL (UNII: 6DC9Q167V3) | Â |
| STARCH, CORN (UNII: O8232NY3SJ) | Â |
|
| Product Characteristics |
| Color | white (white) | Score | no score |
| Shape | ROUND | Size | 11mm |
| Flavor | | Imprint Code |
44;157;ASPIRIN
|
| Contains | Â Â Â Â |
|
| 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 | 08/26/2010 | |
|
| Part 7 of 7 |
ANTISEPTIC TOWELETTEÂ
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 | 0.40 mL  in 100 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | Â |
|
|
| 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 final | part333E | 09/09/2010 | |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333B | 08/26/2010 | |
|