Label: OXYGEN gas

  • NDC Code(s): 58987-001-01, 58987-001-02, 58987-001-03, 58987-001-04, view more
    58987-001-05, 58987-001-06
  • Packager: Enos Home Oxygen Therapy, 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 October 22, 2023

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

  • WARNINGS AND PRECAUTIONS

    WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications Rx only.

    DO NOT REMOVE THIS LABEL

    enoshp02

  • OXYGEN COMPRESSED LABEL

    OXYGEN COMPRESSED U.S.P.  UN 1072 Oxygen produced by air liquefaction Warning: Oxidizing gas which vigorously accelerates combustion. Handle and store with care. Do not drop. Keep upright. Do not use or store near heat or flame. Keep free from oil or grease. Use only with equipment designed, cleaned and rated for use with medical oxygen systems. Open valve slowly. Close valve after each use and when empty. Uninterrupted use of high concentrations of oxygen over an extended period of time without monitoring its effects may be harmful. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.

    Filled by: ENOS HOME OXYGEN AND MEDICAL SUPPLY, INC.
    35 Welby Road New Bedford, MA 02745
    508-992-2146 1-800-473-4669

    enoshp02

  • OXYGEN REFRIGERATED LIQUID LABEL

    OXYGEN REFRIGERATED LIQUID U.S.P. UN 1073Oxygen produced by air liquefaction Warning: Oxidizing gas which vigorously accelerates combustion. Handle and store with care. Do not drop. Keep upright. Do not use or store near heat or flame. Keep free from oil or grease. Use only with equipment designed, cleaned and rated for use with medical oxygen systems. Open valve slowly. Close valve after each use and when empty. Uninterrupted use of high concentrations of oxygen over an extended period of time without monitoring its effects may be harmful. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.

    Filled by: ENOS HOME OXYGEN AND MEDICAL SUPPLY, INC.
    35 Welby Road New Bedford, MA 02745
    508-992-2146 1-800-473-4669


    enosliq02

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58987-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99.5 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58987-001-01113 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1985
    2NDC:58987-001-02165 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1985
    3NDC:58987-001-03240 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1985
    4NDC:58987-001-04415 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1985
    5NDC:58987-001-05682 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1985
    6NDC:58987-001-063450 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1985
    Labeler - Enos Home Oxygen Therapy, Inc. (089350771)
    Registrant - Enos Home Oxygen Therapy, Inc. (089350771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enos Home Oxygen Therapy, Inc.089350771manufacture(58987-001)