Label: OXYGEN - oxygen gas
- NDC Code(s): 53425-001-01, 53425-001-02, 53425-001-03, 53425-001-04
- Packager: IWS Gas and Supply of Texas, LTD
- 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.
Updated November 14, 2012
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- PRINCIPAL DISPLAY PANEL
OXYGEN REFRIGERATED LIQUID, USP OXYGEN 2Close
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.
IN CASE OF FROSTBITE, obtain medical treatment immediately.
PLEASE REFER TO THE MATERIAL SAFETY DATA SHEET FOR SAFETY AND PRODUCT INFORMATION.
DO NOT REMOVE THIS PRODUCT LABEL
- PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP OXYGEN 2Close
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
- INGREDIENTS AND APPEARANCE
Product 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 2 NDC:53425-001-02 708 L in 1 CYLINDER 3 NDC:53425-001-03 425 L in 1 CYLINDER 4 NDC:53425-001-04 172365 L in 1 DEWAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 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 963374793 manufacture(53425-001)