Label: OXYGEN gas
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NDC Code(s):
46123-002-01,
46123-002-02,
46123-002-03,
46123-002-04, view more46123-002-05, 46123-002-06, 46123-002-07, 46123-002-08
- 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
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
OXYGEN,
REFRIGERATED LIQUID
USP
UN1073
ROBERTS OXYGEN COMPANY, INC.
P.O. Box 5507 ROCKVILLE, MD. 20855
301-948-8100
↑ALWAYS KEEP CONTAINER IN UPRIGHT POSITION↑
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. 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. Produced by Air Liquefaction.
Keep out of reach of children; and Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.
DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.
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 fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop leak if safe to do so. Use a back flow preventative device in the piping. Use only with equipment cleaned for oxygen service. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get medical advice/attention immediately.
DO NOT REMOVE THIS PRODUCT LABEL.
CAS: 7782-44-7
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-002 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:46123-002-01 127446 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1970 2 NDC:46123-002-02 198362 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1970 3 NDC:46123-002-03 134991 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1970 4 NDC:46123-002-04 146414 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1970 5 NDC:46123-002-05 169926 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1970 6 NDC:46123-002-06 152935 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1970 7 NDC:46123-002-07 273152 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1970 8 NDC:46123-002-08 325000 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1970 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(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 037669104 manufacture(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 094888112 manufacture(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 116950907 manufacture(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 121820476 manufacture(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 783854045 manufacture(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 788511095 manufacture(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 791818008 manufacture(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 926687468 manufacture(46123-002) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 959266628 manufacture(46123-002)