OXYGEN - oxygen gas 
Maniilaq Association

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PRINCIPAL DISPLAY PANEL

MANIILAQ HEALTH CENTER
USP 93% OXYGEN
H-01
50789-436-01 OXYGEN H CYLINDER 6900 LITER

OXYGEN 93%
U.S.P.

OXYGEN
2

Net Contents:
Oxygen (O2):  93% ± 3%
Nitrogen (N2):  4% ±  2%
Argon (Ar):  3% ± 1.5%
Carbon Dioxide (CO2):  <300 ppm
Carbon Monoxide (CO):  <10 ppm

WARNING:  HIGH PRESSURE
OXIDIZING GAS.  VIGOROUSLY
ACCELERATES COMBUSTION.

Keep oil and grease away.
No smoking in cylinder area.
Open and Close valves slowly.
Secure cylinder in storage and use.
Close valve after each use and when empty.
Store and use with adequate ventalation.
Use a backflow preventative device in the piping.
Cylinder temperature should not exceed 52° C (125° F).
Use in accordance with Material Safety Data Sheet (MSDS).
Use only with equipment cleaned for oxygen service and rated for cylinder pressure.

WARNING:  Federal Law prohibits filling this cylinder with Oxygen USP.
This cylinder may only be filled on the CFP oxygen generator system.

For emergency use only when administered by properly trained
personnel for oxygen deficiency and resuscitation.  For all other
medical applications, Rx only.

Uniterrupted use of high concentrations of oxygen over a long duration, without
monitoring its effect on oxygen content of arterial blood may be harmful

Do not attempt to use on patients who have stopped breathing unless used in
conjunction with resuscitative equipment.

Use only with pressure reducing equipment and apparatus designed for oxygen.
Return with at least 25 PSIG pressure.

DO NOT REMOVE THIS PRODUCT LABEL

Oxygen Canister Label
OXYGEN  
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50789-436
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen930 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
Nitrogen (UNII: N762921K75)  
Argon (UNII: 67XQY1V3KH)  
Carbon Dioxide (UNII: 142M471B3J)  
Carbon Monoxide (UNII: 7U1EE4V452)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50789-436-016900 L in 1 CYLINDER
2NDC:50789-436-02660 L in 1 CYLINDER
3NDC:50789-436-03400 L in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/2012
Labeler - Maniilaq Association (081923526)
Establishment
NameAddressID/FEIBusiness Operations
Maniilaq Association081923526MANUFACTURE

Revised: 6/2012
Document Id: 73ff8c2a-88a7-a5be-b001-c7a1e0d1f46e
Set id: fa09ab34-ca75-086f-e1e5-108ba7a66ba6
Version: 1
Effective Time: 20120606
 
Maniilaq Association