Label: OXYGEN gas

  • NDC Code(s): 57971-001-01, 57971-001-02, 57971-001-03, 57971-001-04, view more
    57971-001-05
  • Packager: Franklin Respiratory and Medical, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 23, 2020

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  • Principal for Oxygen Product

    Representative HPLabel

    OXYGEN

    COMPRESSED

    USP

    UN 1072

    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. 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. 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 NO: 7782-44-7

    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:57971-001
    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:57971-001-01164 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2014
    2NDC:57971-001-02255 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2014
    3NDC:57971-001-03425 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2014
    4NDC:57971-001-04680 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2014
    5NDC:57971-001-053455 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas06/01/2014
    Labeler - Franklin Respiratory and Medical, Inc. (180519969)
    Establishment
    NameAddressID/FEIBusiness Operations
    Franklin Respiratory and Medical, Inc.180519969manufacture(57971-001)