Oxygen by Dade Medical, Inc. dba Integrated Home Care / Dade Medical, Inc. dba Integrated Home Care OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Dade Medical, Inc. dba Integrated Home Care , Dade Medical, Inc. dba Integrated Home Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal for Oxygen Product

OXYGEN

COMPRESSED

USP

UN 1072

PRODUCED BY AIR LIQUIFICATION

WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

WARNING: Federal law prohibits dispensing without prescription. 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 conjuction with resuscitative equipment.

WARNING: Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.

USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

DO NOT REMOVE THIS PRODUCT LABEL.

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70672-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70672-001-03	415 L in 1 CYLINDER; Type 0: Not a Combination Product	10/06/2009
2	NDC: 70672-001-04	682 L in 1 CYLINDER; Type 0: Not a Combination Product	10/06/2009
3	NDC: 70672-001-01	165 L in 1 CYLINDER; Type 0: Not a Combination Product	10/06/2009
4	NDC: 70672-001-02	248 L in 1 CYLINDER; Type 0: Not a Combination Product	10/06/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		10/06/2009

Labeler - Dade Medical, Inc. dba Integrated Home Care (808840953)

Establishment
Name	Address	ID/FEI	Business Operations
Dade Medical, Inc. dba Integrated Home Care		080197951	label(70672-001)

Establishment
Name	Address	ID/FEI	Business Operations
Dade Medical, Inc. dba Integrated Home Care		117328961	manufacture(70672-001)

Establishment
Name	Address	ID/FEI	Business Operations
Dade Medical, Inc. dba Integrated Home Care		808840953	manufacture(70672-001)