Label: AIR gas
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Contains inactivated NDC Code(s)
NDC Code(s): 64735-080-01, 64735-080-04, 64735-080-12, 64735-080-13, view more64735-080-21, 64735-080-25, 64735-080-26 - Packager: Air Liquide Healthcare America Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical 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.
Drug Label Information
Updated June 25, 2010
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- Official Label (Printer Friendly)
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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.
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INGREDIENTS AND APPEARANCE
AIR
air gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64735-080 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 23 L in 100 L Nitrogen (UNII: N762921K75) (Nitrogen - UNII:N762921K75) Nitrogen 77 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Business Operations Air Liquide Healthcare America Corporation 067631762 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide Healthcare America Corporation 026523431 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide Healthcare America Corporation 808357268 manufacture