Air, Oxygen and Nitrogen Gas

Dosage Form: gas

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.

AIR USP COMPRESSED

Cylinders B, E, 22, 27, 44, 49

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WARNING: DO NOT HANDLE CYLINDER OR USE CONTENTS UNTIL: 1) YOU HAVE READ AND UNDERSTAND THE MATERIAL SAFETY DATA SHEET FOR THIS PRODUCT.  CALL 1-800-231-1366 FOR MORE COPIES. 2) YOU ARE TRAINED TO USE CYLINDER AND CONTENTS, INCLUDING EMERGENCY PROCEDURES.

CAUTION: HIGH PRESSURE GAS.  MAY ACCELERATE COMBUSTION.  Secure cylinder in storage and use.  Keep oil and grease away.  No smoking in cylinder area.  Use only with equipment rated for cylinder pressure.  Cylinder temperatures should not exceed 125°F (52°C).  Close valve after each use and when empty.  Return with at least 25 PSIG pressure.  Use in accordance with Material Safety Data Sheet.

WARNING:  For breathing support when used by properly trained personnel.  For medical applications, Rx ONLY.  Administration of Medical Air may be hazardous or contraindicated.  For medical use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Medical Air and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.

CAUTION: Federal law prohibits dispensing without prescription. 

CAUTION: USE NO OIL ON VALVE OR CONNECTIONS.  TRANSFILLING OF THIS GAS IS PROHIBITED.

DO NOT REMOVE THIS PRODUCT LABEL.

AIR 
air gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64735-080
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxygen (Oxygen ) Oxygen 23 L  in 100 L
Nitrogen (Nitrogen) Nitrogen 77 L  in 100 L
Packaging
# Item Code Package Description
1 NDC:64735-080-01 198 L in 1 CYLINDER
2 NDC:64735-080-04 708 L in 1 CYLINDER
3 NDC:64735-080-12 3540 L in 1 CYLINDER
4 NDC:64735-080-13 4390 L in 1 CYLINDER
5 NDC:64735-080-21 7108 L in 1 CYLINDER
6 NDC:64735-080-25 8609 L in 1 CYLINDER
7 NDC:64735-080-26 9544 L in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/1960
Labeler - Air Liquide Healthcare America Corporation (087757167)
Establishment
Name Address ID/FEI Operations
Air Liquide Healthcare America Corporation 067631762 manufacture
Establishment
Name Address ID/FEI Operations
Air Liquide Healthcare America Corporation 026523431 manufacture
Establishment
Name Address ID/FEI Operations
Air Liquide Healthcare America Corporation 808357268 manufacture
Revised: 06/2010
 
Air Liquide Healthcare America Corporation



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