Label: OXYGEN- oxygen gas
- Packager: Compressed Gas Solutions Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated January 19, 2017
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- PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
PRODUCED BY AIR LIQUEFACTION
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications. RX only. Uninterrupted 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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINES GAS UNDER PRESSURE; MAY EXPLODE IF HEATHER. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the pipping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use. CAS 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
COMPRESSED GAS SOLUTIONS, INC.
2450 SHADER RD
ORLANDO, FL 32804
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67596-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 995 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67596-001-01 416 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001 2 NDC:67596-001-02 685 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001 3 NDC:67596-001-03 3554 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001 4 NDC:67596-001-04 7108 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001 5 NDC:67596-001-05 9544 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205827 11/01/2001 Labeler - Compressed Gas Solutions Inc (122401982) Establishment Name Address ID/FEI Business Operations Compressed Gas Solutions Inc 122401982 manufacture(67596-001)