Label: OXYGEN gas
-
NDC Code(s):
46123-001-01,
46123-001-02,
46123-001-03,
46123-001-04, view more46123-001-05, 46123-001-06, 46123-001-07, 46123-001-08, 46123-001-09, 46123-001-10, 46123-001-11, 46123-001-12, 46123-001-13, 46123-001-14, 46123-001-15
- Packager: Roberts Oxygen Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 16, 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
USP
UN1072
OXYGEN 2
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. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fitting free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventative device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. CAS 7782-44-7. DO NOT REMOVE THIS PRODUCT LABEL.
Roberts Oxygen Company, Inc.
PO Box 5507 Rockville, MD 20855
301-948-8100
-
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46123-001-01 170 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 2 NDC:46123-001-02 181 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 3 NDC:46123-001-03 246 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 4 NDC:46123-001-04 425 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 5 NDC:46123-001-05 587 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 6 NDC:46123-001-06 651 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 7 NDC:46123-001-07 705 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 8 NDC:46123-001-08 1048 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 9 NDC:46123-001-09 3993 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 10 NDC:46123-001-10 7986 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 11 NDC:46123-001-11 9346 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 12 NDC:46123-001-12 4163 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 13 NDC:46123-001-13 212 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 14 NDC:46123-001-14 34 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 15 NDC:46123-001-15 112147 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 01/01/1967 Labeler - Roberts Oxygen Company, Inc. (042646877) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 020325953 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 037669104 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 094888112 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 116950907 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 121820476 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 783854045 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 788511095 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 791818008 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 926687468 manufacture(46123-001) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 959266628 manufacture(46123-001)