MODEL AA-1218 MODEL AA-1218M MODEL Z-25-020-03- first aid kit with drug   
Aerospace Accessory Service, Inc

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Model AA-1218
Model AA-1218M
Model Z-25-020-03

Aerospace Accessory Service 

Aerospace Accessory Service

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S/N:

EXP:

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Label

MODEL AA-1218 MODEL AA-1218M MODEL Z-25-020-03 
first aid kit with drug kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:27860-007
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:27860-007-031 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1 1 
Part 2 1 
Part 3 1 
Part 1 of 3
POVIDONE-IODINE 
povidone-iodine solution
Product Information
Item Code (Source)NDC:46414-7777
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/14/1976
Part 2 of 3
AMMONIA INHALANTS 
ammonia inhalants inhalant
Product Information
Item Code (Source)NDC:46414-3333
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/14/1976
Part 3 of 3
DYNAREX BURN CREAM 
lidocaine cream
Product Information
Item Code (Source)NDC:67777-412
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceABC01/01/2015
Labeler - Aerospace Accessory Service, Inc (859100547)
Registrant - Aerospace Accessory Service, Inc (859100547)
Establishment
NameAddressID/FEIBusiness Operations
Aerospace Accessory Service, Inc859100547manufacture, repack

Revised: 5/2021
Document Id: 629723fd-052a-4716-9cde-5b088b96fa90
Set id: 27e404a1-bbcd-4c3b-b664-07037f88a502
Version: 2
Effective Time: 20210505
 
Aerospace Accessory Service, Inc