NDC | 53425-001-01, 53425-001-02, 53425-001-03, 53425-001-04 |
Set ID | c21fefc5-2696-4268-b88c-452a9abb7012 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | IWS Gas and Supply of Texas, LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NDA205712 |
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PRINCIPAL DISPLAY PANEL
OXYGEN REFRIGERATED LIQUID, USP OXYGEN 2
UN 1073 CRYOGENIC LIQUID Produced by Air Liquefaction
ALWAYS KEEP CONTAINER IN UPRIGHT POSITION
WARNING! EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE.
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, RX only.
WARNING! Uninterrupted use of high concentrations of oxygen over long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment. Keep oil, grease, and combustibles away. Use only with equipment cleaned for oxygen service. Store and use with adequate ventilation. Do not get liquid in eyes, on skin or clothing. For liquid withdrawal, wear face shield and gloves. Do not drop. Use hand truck for container movement. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Use in accordance with Material Safety Data Sheet.
WARNING: Cautions Federal Law Prohibits Dispensing without Prescription.
FIRST AID
IN CASE OF FROSTBITE, obtain medical treatment immediately.
PLEASE REFER TO THE MATERIAL SAFETY DATA SHEET FOR SAFETY AND PRODUCT INFORMATION.
Company Name:
Lot Number:
Contents:
Expiration Date:
DO NOT REMOVE THIS PRODUCT LABEL -
PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP OXYGEN 2
UN1072
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. WARNING: SECURE ALL CYLINDERS WHEN IN STORAGE AND IN USE. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Use in accordance with Material Safety Data Sheet and safety precautions recommended by the supplier. FIRST AID: IF INHALED, remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. Call a physician.
WARNING: FEDERAL LAW PROHIBITS DISPENSING THIS PRODUCT WITHOUT PRESCRIPTION. Produced by air liquefaction. DO NOT REMOVE THIS PRODUCT LABEL.
IWS GAS AND SUPPLY OF TEXAS, LTD
4117 Fair Drive
Pasadena, TX 77507
EMERGENCY PHONE: 713-691-4900
Net Contents: -
PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
UN1072
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. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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 piping. 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 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
GAS AND SUPPLY
105 Rothrock Drive, Bldg. 2
Longview, TX 75602
903-653-0999
CONTENTS:
LTRS:
CU.FT.
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PRINCIPAL DISPLAY PANEL
OXYGEN, REFRIGERATED LIQUID USP
UN1073
ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.
DO NOT CHANGE OR FORCE FIT CONNECTIONS.
CONTENTS: LTRS: CU.FT.
WARNING: USP For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical application, 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.
Produced by Air Liquefaction.
DANGER: MAY CAUSE OF INTENSIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.
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. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
CAS: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
GAS AND SUPPLY
105 Rothrock Drive, Bldg. 2
Longview, TX 75602
903-653-0999
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53425-001 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:53425-001-01 7108 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 2 NDC:53425-001-02 708 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 3 NDC:53425-001-03 425 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 4 NDC:53425-001-04 172365 L in 1 DEWAR; Type 0: Not a Combination Product 07/19/2010 5 NDC:53425-001-05 198 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 6 NDC:53425-001-06 3228 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 7 NDC:53425-001-07 3539 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 8 NDC:53425-001-08 6456 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 9 NDC:53425-001-09 7249 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 10 NDC:53425-001-10 7957 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 11 NDC:53425-001-11 8693 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 12 NDC:53425-001-12 9543 L in 1 CYLINDER; Type 0: Not a Combination Product 07/19/2010 13 NDC:53425-001-13 180 L in 1 DEWAR; Type 0: Not a Combination Product 07/19/2010 14 NDC:53425-001-14 200 L in 1 DEWAR; Type 0: Not a Combination Product 07/19/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205712 07/19/2010 Labeler - IWS Gas and Supply of Texas, LTD (963374793) Establishment Name Address ID/FEI Business Operations IWS GAS AND SUPPLY OF TEXAS, LTD 118170808 manufacture(53425-001) Establishment Name Address ID/FEI Business Operations IWS Gas and Supply of Texas, LTD 963374793 manufacture(53425-001)