OXYGEN by Alternacare Home Health Services OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Alternacare Home Health Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

WARNING:
HIGH PRESSURE GAS CYLINDER

Improper filling or abuse of this cylinder, or failure to heed this warning may cause serious injury or loss of life. DO NOT ALTER OR MODIFY CYLINDER OR RELATED COMPONENTS. DO NOT OVER PRESSURIZE. Keep out of the reach of children. Cylinders that have been refinished and/or exposed to elevated temperatures must be hydrostatically tested before filling. Do not use caustic paint strippers. Aluminum cylinders subject to action of fire or heated to temperatures in excess of 350 F must be withdrawn from service and condemned. Valves and safety relief devices must be removed and replaced by trained personnel. Do not alter or change safety discs. Replace pressure relief devices only with complete assemblies supplied by the valve manufacturer. DO NOT FILL WITH OXIDIZING GASES WITHOUT PROPER CLEANING. Cylinders, valves and assemblies must be specially cleaned for oxygen. Verify cylinder content and pressure monthly, or more frequently if required. Store and use with adequate ventilation.

WARNINGS

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.

WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATED COMBUSTION

Use only with pressure reducing equipment and apparatus cleaned and designed for oxygen service and rated for cylinder pressure.

Open valve slowly. Close valve after each use and when empty. Keep cylinder, cylinder valve, all equipment that connects, free of oil and grease to avoid violent ignition.

Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance wiith the Federal Food, Drug, and Cosmetic Act.

Pursuant to recommendations by Compressed Gas Association, do not expose pressurized cylinders to temperatures in excess of 125 F

DO NOT REMOVE THIS PRODUCT LABEL

Use a back flow preventative device in the piping.

Use only in accordance with product instructions and material safety data sheet.

PRINCIPAL DISPLAY PANEL

OXYGEN

COMPRESSED

U.S.P. UN 1072

Produced by Air Liquefaction

OXYGEN - 2

Cylinder Contents at 70 F

Type B - 142 liters at 1900 psig

Type C - 235 liters at 1900 psig

Type D - 393 liters at 1900 psig

Type E - 646 liters at 1900 psig

Date code 1104 Label 0035-17(1)

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64097-0001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99.5 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64097-0001-1	142 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
2	NDC: 64097-0001-2	235 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
3	NDC: 64097-0001-3	393 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
4	NDC: 64097-0001-4	646 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1996

Labeler - Alternacare Home Health Services (946763364)

Registrant - Alternacare Home Health Services (946763364)

Establishment
Name	Address	ID/FEI	Business Operations
Alternacare Home Health Services		946763364	manufacture(64097-0001)