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 |
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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
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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
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29149-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29149-001-01 680 L in 1 CYLINDER; Type 0: Not a Combination Product 08/01/2008 2 NDC:29149-001-02 413 L in 1 CYLINDER; Type 0: Not a Combination Product 08/01/2008 3 NDC:29149-001-03 248 L in 1 CYLINDER; Type 0: Not a Combination Product 08/01/2008 4 NDC:29149-001-04 170 L in 1 CYLINDER; Type 0: Not a Combination Product 08/01/2008 5 NDC:29149-001-05 3 L in 1 DEWAR; Type 0: Not a Combination Product 08/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206023 08/01/2008 Labeler - Landmark Healthcare, Inc. (155146173) Establishment Name Address ID/FEI Business Operations Landmark Healthcare Inc 049435453 manufacture(29149-001)