Oxygen by Landmark Healthcare, Inc. / Landmark Healthcare Inc OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Landmark Healthcare, Inc., Landmark Healthcare Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product 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)