Label: OXYGEN gas

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    57439-003-01, 57439-003-02, 57439-003-03, 57439-003-04, view more
    57439-003-05, 57439-003-06, 57439-003-07, 57439-003-08, 57439-003-09, 57439-003-10, 57439-003-11, 57439-003-12, 57439-003-13, 57439-003-14, 57439-003-15
  • Packager: Rotech Healthcare Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 15, 2022

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP

    UN1072

    PRODUCED BY AIR LIQUEFACTION

    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. Keep out of reach of children. 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 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 fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. 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. oxygen one

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP

    UN1073

    PRODUCED BY AIR LIQUEFACTION

    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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only be 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 well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop the flow of oxygen if safe to do so. Use a back flow preventive 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. 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 immediate medical advice/attention. CAS: 7782-44-7

    DO NOT REMOVE THIS PRODUCT LABEL oxygen two

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57439-003
    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:57439-003-083455 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    2NDC:57439-003-097100 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    3NDC:57439-003-109430 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    4NDC:57439-003-01113 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    5NDC:57439-003-02170 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    6NDC:57439-003-03255 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    7NDC:57439-003-04425 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    8NDC:57439-003-05680 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    9NDC:57439-003-061738 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    10NDC:57439-003-072549 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
    11NDC:57439-003-1120 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
    12NDC:57439-003-1230 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
    13NDC:57439-003-1332 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
    14NDC:57439-003-1437 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
    15NDC:57439-003-1545 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20588901/01/2018
    Labeler - Rotech Healthcare Inc (144556222)
    Registrant - Rotech Healthcare Inc (144556222)
    Establishment
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    Establishment
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    Establishment
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    Oxygen Plus, Inc. dba Summit Respiratory079569918manufacture(57439-003)
    Establishment
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    Establishment
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    Establishment
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    Establishment
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    Establishment
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    Establishment
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    Establishment
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    Establishment
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    HOME MEDICAL SYSTEMS795469142manufacture(57439-003)
    Establishment
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    Establishment
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    G&G MEDICAL796502479manufacture(57439-003)
    Establishment
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    ROTH MEDICAL831552364manufacture(57439-003)
    Establishment
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    Establishment
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    Establishment
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    FAMILY HOME CARE831748491manufacture(57439-003)
    Establishment
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    GREAT LAKES HOME MEDICAL831831172manufacture(57439-003)
    Establishment
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    ROTECH833186922manufacture(57439-003)
    Establishment
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    MED-AIR TRANSFILL841973667manufacture(57439-003)
    Establishment
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    SUMMIT RESPIRATORY874476422manufacture(57439-003)
    Establishment
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    ROTH MEDICAL948744180manufacture(57439-003)
    Establishment
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    VITALCARE HEALTH SERVICES956721187manufacture(57439-003)