MODEL AA-1218 MODEL AA-1218M MODEL Z-25-020-03- kit

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

Drug Labeling and Warnings

Model AA-1218 Model AA-1218M Model Z-25-020-03 by is a Other medication manufactured, distributed, or labeled by Aerospace Accessory Service, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Aerospace Accessory Service 

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 kit

Product 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 solution

Product 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 inhalant

Product 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 cream

Product 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