OXYGEN GAS [SMITH'S HOME MEDICAL EQUIPMENT, INC.]

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OXYGEN GAS [SMITH'S HOME MEDICAL EQUIPMENT, INC.]
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NDC 35420-123-01, 35420-123-02, 35420-123-03
Set ID 7b0b3b9f-4c2d-5bb2-e053-2991aa0aca0b
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Smith's Home Medical Equipment, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • Principal for Oxygen Product

    Representative HP Label

    OXYGEN

    COMPRESSED

    USP

    UN 1072

    PRODUCED BY AIR LIQUIFICATION

    WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

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

    WARNING: Federal law prohibits dispensing without prescription. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjuction with resuscitative equipment.

    WARNING: Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.

    USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

    DO NOT REMOVE THIS PRODUCT LABEL.

    RepresentativeLotSticker

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:35420-123
    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:35420-123-01164 L in 1 CYLINDER; Type 0: Not a Combination Product02/20/2012
    2NDC:35420-123-02425 L in 1 CYLINDER; Type 0: Not a Combination Product02/20/2012
    3NDC:35420-123-03680 L in 1 CYLINDER; Type 0: Not a Combination Product02/20/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas02/20/2012
    Labeler - Smith's Home Medical Equipment, Inc. (932241920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Smith's Home Medical Equipment, Inc.932241920manufacture(35420-123)
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