Label: OXYGEN gas
-
NDC Code(s):
66878-001-01,
66878-001-02,
66878-001-03,
66878-001-04, view more66878-001-05, 66878-001-06, 66878-001-07, 66878-001-08, 66878-001-09, 66878-001-10, 66878-001-11, 66878-001-12, 66878-001-13, 66878-001-14, 66878-001-15, 66878-001-16, 66878-001-18, 66878-001-19, 66878-001-20
- Packager: GC Medical Equipment, Inc.
- 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.
Drug Label Information
Updated October 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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 gasProduct 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)