Label: OXYGEN gas

  • 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 January 1, 2010

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  • Certificate of Analysis

    CERTIFICATE OF ANALYSIS   UNIT NUMBER___________ SERIAL NUMBER___________ AMOUNT_________________INS, LBS, LITERS, CU FT.

    USP TESTS

    TEST      ID      ODOR      ASSAY

    LIMITS   OK      NONE         99.2%

    RESULT __           _____          _____

    FOR CUSTOMERS USE TO DOCUMENT TESTS PERFORMED ON THIS VESSEL IF TESTING WAS NOT WITNESSED

    TEST      ID      ODOR      ASSAY

    LIMITS   OK      NONE         99.2%

    RESULT __           _____          _____

    CUSTOMER WITNESSED TESTS? _YES  ___NO

    OXYGEN PURITY AND ID TESTED WITH A __________ ANALYZER MODEL NO_________   ABSENCE OF ODOR CONFIRMED BY THE OLIFACTORY METHOD _________  SUPPLIERS SIGNATURE_____________________ DATE____________  CUSTOMERS SIGNATURE_____________DATE____________   ENTER LOT NUMBER AND PLACE STICKER HERE________________ EXPIRATION DATE__________



    MEDICAL GASES LIQUID OXYGEN U.S.P. DELIVERY TAG  FILLED BY: (PLEASE STAMP LOCATION ADDRESS OR PLACE LABEL BELOW)   THIS VESSEL CONTAINS OXYGEN U.S.P. (SEE REVERSE SIDE FOR TEST RESULTS)  OXYGEN PRODUCED BY THE AIR LIQUEFACTION METHOD


    COA FRONT

    COA BACK


  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52200-001
    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:52200-001-0121 L in 1 DEWAR
    2NDC:52200-001-0231 L in 1 DEWAR
    3NDC:52200-001-0336 L in 1 DEWAR
    4NDC:52200-001-0441 L in 1 DEWAR
    5NDC:52200-001-0545 L in 1 DEWAR
    6NDC:52200-001-0646 L in 1 DEWAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1981
    Labeler - Home Care Medical LLC (043751499)
    Registrant - Home Care Medical LLC (043751499)
    Establishment
    NameAddressID/FEIBusiness Operations
    Home Care Medical LLC043751499manufacture