Label: OXYGEN gas

  • NDC Code(s): 65386-0001-1, 65386-0001-2, 65386-0001-3
  • Packager: Advacare Home Services, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

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Drug Label Information

Updated November 12, 2024

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  • Principal for Oxygen Product

    RepresentativeLOXLabel

    OXYGEN,

    REFRIGERATED

    LIQUID USP

    UN 1073

    CONTENTS ________________LITERS

    CAS NO: 7782-44-7

    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 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.

    DO NOT REMOVE THIS PRODUCT LABEL.

    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.

    RepresentativeLotSticker

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65386-0001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65386-0001-131 L in 1 DEWAR; Type 0: Not a Combination Product10/28/2009
    2NDC:65386-0001-241 L in 1 DEWAR; Type 0: Not a Combination Product10/28/2009
    3NDC:65386-0001-346 L in 1 DEWAR; Type 0: Not a Combination Product10/28/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas10/28/2009
    Labeler - Advacare Home Services, Inc. (068450365)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advacare Home Services, Inc.008190379manufacture(65386-0001)