OXYGEN GAS [LANDMARK HEALTHCARE, INC.]

OXYGEN GAS [LANDMARK HEALTHCARE, INC.]
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NDC 29149-001-01, 29149-001-02, 29149-001-03, 29149-001-04, 29149-001-05
Set ID cca09fe2-3b75-41f2-9f50-86d48ffa1c56
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Landmark Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number NDA206023
  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP UN1072

    Produced by Air Liquefication

    OXYGEN 2

    WARNING: For emergency use only when administered by properly trained personnel for oxygen

    deficiency and resuscitation. For all other 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. Keep out of reach of children.

    Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act.

    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 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 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: 7782-44-7

    NET CONTENTS

    CYLINDER TYPES LITERS

    E 680

    D 413

    C 248

    B 170

    DO NOT REMOVE THIS PRODUCT LABEL.

    LANDMARK HEALTHCARE

    8200 Tristar Drive, Suite 120 Irving, Texas 75063 877-693-0007 un1072

  • PRINCIPAL DISPLAY PANEL

    OXYGEN REFRIGERATED LIQUID, USP UN1073

    Produced by Air Liquefication

    OXYGEN 2

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.

    SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE.

    WARNING:

    For emergency use only when administered by properly trained personnel for oxygen deficiency and

    resuscitation. For all other medical applications, Rx only.

    Caution: 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 conjunction with resuscitative equipment.

    CAS: (7782-44-7)

    WARNING:

    EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE.

    VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID

    OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE.

    Keep oil, grease and combustibles away. Use only with equipment cleaned for oxygen service. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or clothing. For liquid withdrawal, use face shield and gloves. Do not drop. Use suitable hand truck for container movement.

    Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS).

    IN CASE OF FROST BITE, obtain medical treatment immediately.

    DO NOT REMOVE THIS PRODUCT LABEL

    LANDMARK HEALTHCARE

    8200 Tristar Drive, Suite 120 Irving, Texas 75063 877-693-0007 un1073

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:29149-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29149-001-01680 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2008
    2NDC:29149-001-02413 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2008
    3NDC:29149-001-03248 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2008
    4NDC:29149-001-04170 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2008
    5NDC:29149-001-053 L in 1 DEWAR; Type 0: Not a Combination Product08/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20602308/01/2008
    Labeler - Landmark Healthcare, Inc. (155146173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landmark Healthcare Inc049435453manufacture(29149-001)

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