Oxygen by Premier Oxygen LLC OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Premier Oxygen LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GENERAL WARNINGS AND PRECAUTIONS

WARNING: HIGH PRESSURE OXIDIZING GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  STORE AND USE WITH ADEQUATE VENTILATION.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET.  DO NOT REMOVE THIS PRODUCT LABEL.

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP UN 1072  OXYGEN - 2  MEDICAL GAS Rx ONLY.  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 CONCENTRATION 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.  PRODUCED BY AIR LIQUEFACTION

41014 (R07/05)  CAS 7782-44-7

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OXYGEN REFRIGERATED LIQUID LABEL

REFRIGERATED LIQUID
OXYGEN,
REFRIGERATED
LIQUID

USP
UN1073

OXYGEN
2
(R-K14) 116046

DANGER: ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.
               DO NOT CHANGE OR FORCE FIT CONNECTIONS.
               MAY CAUSE OR INTENSIFY FIRE: OXIDIZER.
               CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC
                  BURNS OR INJURY.
               COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY
               EXPLODE ON IGNITION OR IMPACT.

               Do not handle until all safety precautions have been read
                 and understood.
               Keep and store away from clothing and other combustible
                   materials.
               Keep valves and fittings free from grease and oil.
               Use and store only outdoors or in a well-ventilated place.
               Wear cold insulating gloves, face shield, and eye protection.
               In case of fire: Stop leak if safe to do so.
               Use aback flow preventive device in the piping.
               Use only with equipment of compatible materials of construction
                 and rated for cylinder pressure.
               Use only with equipment cleaned for oxygen service.

DO NOT change or force fit connections.
Avoid spills. Do not walk on or roll equipment over spills.
Close valve after each use and when empty.
Always keep container in upright position.
Read and follow the Safety DataSheet (SDS) before use.

WARNING: For emergency use only when administered by properly trained personnel for oxygen
                  deficiency and resuscitation. For all other medical applications. Rx only.
                  Uninterrupted use of high concentrations of oxygen over a long duration. without monitoring its
                  effect on oxygen content 01 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.

FIRSTAID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not
rub affected area. Get immediate medical advice/attention.

DO NOT REMOVE THIS PRODUCT LABEL.

Premier Oxygen, LLC
2185 NE Spalding Avenue
Grants Pass, OR 97526
(888) 9779339

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INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 67932-1313
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99.5 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67932-1313-1	165 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1988
2	NDC: 67932-1313-2	425 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1988
3	NDC: 67932-1313-3	680 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1988
4	NDC: 67932-1313-4	255 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1988
5	NDC: 67932-1313-5	1750 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1988
6	NDC: 67932-1313-8	26 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1988

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1988

Labeler - Premier Oxygen LLC (013568474)

Registrant - Premier Oxygen LLC (013568474)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Oxygen LLC		013568474	manufacture(67932-1313)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Oxygen LLC		140880423	manufacture(67932-1313)