Oxygen by IWS Gas and Supply of Texas, LTD / IWS GAS AND SUPPLY OF TEXAS, LTD OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by IWS Gas and Supply of Texas, LTD, IWS GAS AND SUPPLY OF TEXAS, LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

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; 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

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		963374793	manufacture(53425-001)