OXYGEN by PURITY CYLINDER GASES INC OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by PURITY CYLINDER GASES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP
UN1072
PRODUCED BY AIR LIQUEFACTION
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and applications. For all other medical application, 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 establishment 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 other 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 of 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 DO NOT REMOVE THIS PRODUCT LABEL.
Contents (Cu Ft): T-337 H-251 M-125 E-24 D-14
C-9 B-6 OTHER:
PURITY CYLINDER GASES, INC.
2580 28TH ST SW, WYOMING, MI 49519
616-532-2375

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10927-003
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: 10927-003-09	113 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
2	NDC: 10927-003-10	142 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
3	NDC: 10927-003-11	255 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
4	NDC: 10927-003-12	396 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
5	NDC: 10927-003-13	651 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
6	NDC: 10927-003-14	1388 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
7	NDC: 10927-003-15	1699 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
8	NDC: 10927-003-16	3597 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
9	NDC: 10927-003-17	7420 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
10	NDC: 10927-003-18	9657 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938
11	NDC: 10927-003-19	1132.68 L in 1 CYLINDER; Type 0: Not a Combination Product	10/20/1938

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205767	10/20/1938

Labeler - PURITY CYLINDER GASES INC (065878860)

Establishment
Name	Address	ID/FEI	Business Operations
PURITY CYLINDER GASES INC		006055710	manufacture(10927-003)

Establishment
Name	Address	ID/FEI	Business Operations
PURITY CYLINDER GASES INC		016676728	manufacture(10927-003)

Establishment
Name	Address	ID/FEI	Business Operations
PURITY CYLINDER GASES INC		120042374	manufacture(10927-003)