Label: MODEL AA-1218 MODEL AA-1218M MODEL Z-25-020-03- kit
- NHRIC Code(s): 27860-007-03
- Packager: Aerospace Accessory Service, Inc
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated May 5, 2021
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- Aerospace Accessory Service
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INGREDIENTS AND APPEARANCE
MODEL AA-1218 MODEL AA-1218M MODEL Z-25-020-03
first aid kit with drug kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:27860-007 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:27860-007-03 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 3 1 Part 1 of 3 POVIDONE-IODINE
povidone-iodine solutionProduct Information Item Code (Source) NDC:46414-7777 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/14/1976 Part 2 of 3 AMMONIA INHALANTS
ammonia inhalants inhalantProduct Information Item Code (Source) NDC:46414-3333 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g in 0.3 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/14/1976 Part 3 of 3 DYNAREX BURN CREAM
lidocaine creamProduct Information Item Code (Source) NDC:67777-412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.5 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) CETETH-20 (UNII: I835H2IHHX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) GLYCERIN (UNII: PDC6A3C0OX) EDETATE SODIUM (UNII: MP1J8420LU) WATER (UNII: 059QF0KO0R) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date exempt device ABC 01/01/2015 Labeler - Aerospace Accessory Service, Inc (859100547) Registrant - Aerospace Accessory Service, Inc (859100547) Establishment Name Address ID/FEI Business Operations Aerospace Accessory Service, Inc 859100547 manufacture, repack
