Label: OXYGEN gas
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NDC Code(s):
66365-001-01,
66365-001-02,
66365-001-03,
66365-001-04, view more66365-001-05, 66365-001-06, 66365-001-07, 66365-001-08, 66365-001-09, 66365-001-10, 66365-001-11, 66365-001-12
- Packager: Medical Comfort Systems Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 8, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
PRODUCED BY AIR LIQUEFACTION
OXYGEN, COMPRESSED USP
UN 1072
DO NOT REMOVE THIS PRODUCT LABEL
DANGER:
COMPRESSED, OXIDIZING GAS, MAY CAUSE OR INTENSIFY FIRE, OXIDIZER, CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED
NO SMOKING
NO VAPING
NO OPEN FLAME
Federal law requires that this container be filled with oxygen USP only by establishments registered as a drug producer in accordance with the Federal food, drug and cosmetics act. Keep out of reach of children. Do not use or store near heat or open flame.
WARNING: HIGH PRESSURE, OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION.
NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.
Keep oil and grease away. Open valve slowly. Store and use with adequate pressure.
Use only with equipment cleaned for oxygen service and rated for cylinder pressure.
Use a back flow preventive device in the piping.
Close valve after each use and when empty. Cylinder temperature should not exceed 52 C (125 F).
Use in accordance with Safety Data Sheet (SDS)
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical application, Rx Required. 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.
CAS NO: 7782-7 E 682 Liters
M6/B 165 Liters M 3458 Liters
M9/C 248 Liters M60 1738 Liters
D 415 Liters Other Liters
Medical Comfort Systems
112-A White Oak Lane
Lexington, SC 29073
(800) 765-4697
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66365-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 998 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66365-001-01 70 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2001 2 NDC:66365-001-02 248 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2001 3 NDC:66365-001-03 415 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2001 4 NDC:66365-001-04 682 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2001 12/31/2022 5 NDC:66365-001-05 1724 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2001 6 NDC:66365-001-06 3452 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2001 12/31/2022 7 NDC:66365-001-07 16750 L in 1 DEWAR; Type 0: Not a Combination Product 06/01/2001 8 NDC:66365-001-08 24950 L in 1 DEWAR; Type 0: Not a Combination Product 06/01/2001 12/31/2022 9 NDC:66365-001-09 29069 L in 1 DEWAR; Type 0: Not a Combination Product 06/01/2001 10 NDC:66365-001-10 33500 L in 1 DEWAR; Type 0: Not a Combination Product 06/01/2001 12/31/2022 11 NDC:66365-001-11 37619 L in 1 DEWAR; Type 0: Not a Combination Product 06/01/2001 12 NDC:66365-001-12 38300 L in 1 DEWAR; Type 0: Not a Combination Product 06/01/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 06/01/2001 Labeler - Medical Comfort Systems Inc (037401429) Establishment Name Address ID/FEI Business Operations Medical Comfort Systems Inc 037401429 manufacture(66365-001)