Model 2004FAA Model 3-EEMK Model 3-EEMK-1 Model AA-8565 Model AA-8565-LATAM Model AWFAREMK Model CHAUTAUQUAEMK Model Emk1000-10 Model FAREMK Model PMONTFAREMK Model SWEEMK Model SWEEMK-1…: Package Insert and Label Information

MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)-
Aerospace Accessory Service, Inc

Aerospace Accessory Service

Aerospace Accessory Service

P/N:

S/N:

EXP:

Prep. By:

Label
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
Model 2004FAA Model 3-EEMK Model 3-EEMK-1 Model AA-8565 Model AA-8565-LATAM Model AWFAREMK Model CHAUTAUQUAEMK Model emk1000-10 Model FAREMK Model PMONTFAREMK Model SWEEMK Model SWEEMK-1 Model QXEMK Model G4FAREMK Model AA-8565 (excluding Miami Air) Emergency Response Safety Kit
MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR) kit
Product Information
Product Type Item Code (Source) NHRIC:27860-001
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:27860-001-13 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1
Part 2 1
Part 3 1
Part 4 1
Part 5 1
Part 6 1
Part 7 1
Part 8 1
Part 9 1
Part 10 1
Part 11 1
Part 12 1
Part 13 1
Part 14 1
Part 15 1
Part 16 1
Part 17 1
Part 18 1
Part 19 1
Part 20 1
Part 21 1
Part 22 1
Part 23 1
Part 24 1
Part 25 1
Part 26 1
Part 27 1
Part 1 of 27
SODIUM CHLORIDE sodium chloride injection, solution
Product Information
Item Code (Source) NDC:0338-0049
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE 9 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016677 12/09/1970
Part 2 of 27
SODIUM CHLORIDE sodium chloride injection, solution
Product Information
Item Code (Source) NDC:0264-7800
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE 0.9 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019635 03/09/1988
Part 3 of 27
ATROPINE SULFATE atropine sulfate injection, solution
Product Information
Item Code (Source) NDC:0409-4910
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ENDOTRACHEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM HYDROXIDE
SULFURIC ACID
WATER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021146 01/19/2006
Part 4 of 27
ATROPINE SULFATE atropine sulfate injection
Product Information
Item Code (Source) NDC:76329-3339
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Atropine Sulfate (ATROPINE) Atropine Sulfate 0.1 mg in 1 mL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2000
Part 5 of 27
EPINEPHRINE epinephrine injection
Product Information
Item Code (Source) NDC:76329-3316
Route of Administration INTRAVENOUS, INTRACARDIAC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Epinephrine (EPINEPHRINE) Epinephrine 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Bisulfite
Sodium Chloride
Hydrochloric Acid
Sodium Citrate
Citric Acid Monohydrate
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/1976
Part 6 of 27
EPINEPHRINE epinephrine injection, solution
Product Information
Item Code (Source) NDC:0409-4933
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Epinephrine (EPINEPHRINE) Epinephrine 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
SODIUM METABISULFITE
ANHYDROUS CITRIC ACID
TRISODIUM CITRATE DIHYDRATE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209359 03/10/2021
Part 7 of 27
EPINEPHRINE epinephrine injection, solution
Product Information
Item Code (Source) NDC:0409-4921
Route of Administration INTRAVENOUS, INTRACARDIAC, ENDOTRACHEAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM METABISULFITE
ANHYDROUS CITRIC ACID
TRISODIUM CITRATE DIHYDRATE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/14/2005 01/01/2017
Part 8 of 27
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:0409-1323
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040302 12/09/2005
Part 9 of 27
LIDOCAINE lidocaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:63323-208
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017584 09/05/2000
Part 10 of 27
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection
Product Information
Item Code (Source) NDC:76329-3390
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083173 06/01/2001
Part 11 of 27
DEXTROSE MONOHYDRATE dextrose monohydrate injection
Product Information
Item Code (Source) NDC:76329-3301
Route of Administration PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 500 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2000
Part 12 of 27
DEXTROSE dextrose monohydrate injection, solution
Product Information
Item Code (Source) NDC:0409-6648
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 25 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019445 12/02/2005
Part 13 of 27
NITROGLYCERIN nitroglycerin tablet
Product Information
Item Code (Source) NDC:68462-639
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 0.4 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
SILICA DIMETHYL SILYLATE
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND (Flat faced) Size 4mm
Flavor Imprint Code 2;C
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206391 08/19/2017
Part 14 of 27
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride injection
Product Information
Item Code (Source) NDC:0641-0376
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080817 11/27/1972
Part 15 of 27
EPINEPHRINE epinephrine injection, solution, concentrate
Product Information
Item Code (Source) NDC:54288-103
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Epinephrine (EPINEPHRINE) Epinephrine 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Hydrochloric Acid
Water
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205029 08/08/2014
Part 16 of 27
EASY CARE FIRST AID DIPHENHYDRAMINE diphenhydramine hydrochloride tablet, film coated
Product Information
Item Code (Source) NDC:4422-0017
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color pink (pink) Score no score
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code 048;D
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/01/2012
Part 17 of 27
ALCOHOL PREP isopropyl alcohol swab
Product Information
Item Code (Source) NDC:67777-121
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/01/2010
Part 18 of 27
MOORE MEDICAL NON ASPIRIN acetaminophen tablet, film coated
Product Information
Item Code (Source) NDC:55670-467
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code AZ;234
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 12/30/2008
Part 19 of 27
ASPIRIN aspirin tablet, film coated
Product Information
Item Code (Source) NDC:55670-131
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MINERAL OIL
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code TCL;011
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 12/30/2008 08/31/2022
Part 20 of 27
MOOREBRAND ASPIRIN aspirin tablet, film coated
Product Information
Item Code (Source) NDC:55670-616(NDC:50844-957)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code Aspirin;44;157
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/05/2020
Part 21 of 27
VENTOLIN HFA albuterol sulfate aerosol, metered
Product Information
Item Code (Source) NDC:0173-0682
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 90 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020983 06/09/2006
Part 22 of 27
ALBUTEROL SULFATE HFA albuterol sulfate aerosol, metered
Product Information
Item Code (Source) NDC:66993-019
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 90 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020983 01/15/2019
Part 23 of 27
ALBUTEROL SULFATE albuterol sulfate aerosol, metered
Product Information
Item Code (Source) NDC:45802-088
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 90 ug
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
NORFLURANE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203760 02/26/2020
Part 24 of 27
ALBUTEROL SULFATE HFA albuterol sulfate aerosol, metered
Product Information
Item Code (Source) NDC:0093-3174
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 90 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE
ALCOHOL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021457 01/16/2019
Part 25 of 27
ALBUTEROL SULFATE albuterol sulfate inhalant
Product Information
Item Code (Source) NDC:69097-142
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 108 ug
Inactive Ingredients
Ingredient Name Strength
OLEIC ACID
NORFLURANE
ALCOHOL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209959 04/08/2020
Part 26 of 27
ALBUTEROL SULFATE albuterol sulfate aerosol, metered
Product Information
Item Code (Source) NDC:0254-1007
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 108 ug
Inactive Ingredients
Ingredient Name Strength
OLEIC ACID
NORFLURANE
ALCOHOL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020503 04/03/2019
Part 27 of 27
PROAIR HFA albuterol sulfate aerosol, metered
Product Information
Item Code (Source) NDC:59310-579
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 90 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE
ALCOHOL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021457 12/03/2012
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 Operations
Aerospace Accessory Service, Inc 859100547 manufacture, repack

Revised: 05/2021 Aerospace Accessory Service, Inc

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