Oxygen by GC Medical Equipment, Inc. OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by GC Medical Equipment, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

OXYGEN, Compressed U.S.P
UN 1072
DANGER
High Pressure oxidizing gas vigorously
accelerates combustion.
Keep away from children.
Produced by AIR LIQUEFICATION
Manufactured/Filled by:
GC MEDICAL EQUIPMENT
4651 State Road, Peninsula, Ohio 44264
888-338-0202
FOR CHEMICAL EMERGENCY
CALL CHEM-TREC 1-800-424-9300
WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY
TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR
ALL MEDICAL APPLICATIONS, Rx ONLY.

KEEP AWAY FROM HEAT, SPARKS OR FLAME. KEEP OIL, GREASE AND COMBUSTBILES
AWAY. ALWAYS SECURE CYLINDERS. OPEN VALVE SLOWLY, CLOSE VALVE AFTER
EACH USE AND WHEN EMPTY. USE IN ACCORDANCE WITH MATERIAL SAFETY
DATA SHEET FOR THIS PRODUCT.
WARNING: 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 EQUIPMENT CLEANED FOR OXYGEN
SERVICE AND RATED FOR CYLINDER PRESSURE. RETURN CYLINDER WITH 25 PSIG PRESSURE
AND CYLINDER CAP SECURED.

FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH GASEOUS OXYGEN U.S.P. ONLY
BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD,
DRUG AND COSMETICS ACT.
CONTENTS: Cylinder Type/Liters E/680 D/425 M9/255 ML6/170 M6/170 M4/113 M2/42
DO NOT REMOVE THIS PRODUCT LABEL.

Oxygen U.S.P.
OXYGEN REFRIGERATED LIQUID UN1073
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.
PRODUCED BY AIR LIQUEFACTION
Warning! Always Keep Container In Upright Position.
For Emergency use only when administered by properly trained personnel for oxygen
deficiency and resuscitation. For all other medical applications, Rx Only.
CAUTION: Federal law prohibits dispensing without prescription.
Uninterrupted use of high concentrations of oxygen over a long duration, without
monitoring its effect on oxygen contents 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.
In Case of Frostbite, obtain Medical treatment IMMEDIATELY.
Keep Out of Reach of Children. Contents under pressure and can vigorously
accelerate combustion. Keep free from oil and grease. Do not use or store near
heat or open flame and use only with equipment conditioned for oxygen service.
Federal law requires that his container be refilled with Liquid Oxygen, U.S.P.
only by establishments registered as a drug producer in accordance with the
Federal Food, Drug and Cosmetic Act.
DO NOT REMOVE THIS LABEL.

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66878-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	991 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66878-001-01	113 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
2	NDC: 66878-001-02	164 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
3	NDC: 66878-001-03	170 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
4	NDC: 66878-001-04	248 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
5	NDC: 66878-001-05	425 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
6	NDC: 66878-001-06	566 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
7	NDC: 66878-001-07	596 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
8	NDC: 66878-001-08	616 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
9	NDC: 66878-001-09	675 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
10	NDC: 66878-001-10	1699 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
11	NDC: 66878-001-11	3450 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
12	NDC: 66878-001-12	7106 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
13	NDC: 66878-001-13	9544 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
14	NDC: 66878-001-14	28 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
15	NDC: 66878-001-15	40 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
16	NDC: 66878-001-16	55 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
17	NDC: 66878-001-18	180 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
18	NDC: 66878-001-19	41 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
19	NDC: 66878-001-20	45 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/03/2011

Labeler - GC Medical Equipment, Inc. (129946943)

Establishment
Name	Address	ID/FEI	Business Operations
GC Medical Equipment, Inc.		129946943	manufacture(66878-001)