OXYGEN GAS [ROBERTS OXYGEN COMPANY, INC.]

OXYGEN GAS [ROBERTS OXYGEN COMPANY, INC.]
PDF | XML

NDC 46123-002-01, 46123-002-02, 46123-002-03, 46123-002-04, 46123-002-05, 46123-002-06, 46123-002-07, 46123-002-08
Set ID fd99ef4b-8a77-455d-b2a6-9a0d19a7b1fe
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Roberts Oxygen Company, Inc.
Generic Name
Product Class
Product Number
Application Number NDA205849
  • 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


    image of dewar label

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-002
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46123-002-01127446 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1970
    2NDC:46123-002-02198362 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1970
    3NDC:46123-002-03134991 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1970
    4NDC:46123-002-04146414 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1970
    5NDC:46123-002-05169926 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1970
    6NDC:46123-002-06152935 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1970
    7NDC:46123-002-07273152 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1970
    8NDC:46123-002-08325000 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1970
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584901/01/1967
    Labeler - Roberts Oxygen Company, Inc. (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.020325953manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.037669104manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.094888112manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.116950907manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.121820476manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.783854045manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.788511095manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.791818008manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.926687468manufacture(46123-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.959266628manufacture(46123-002)

Related Drugs