Oxygen, USP -001

OXYGEN,
COMPRESSED
USP
UN1072
OXYGEN 2
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 of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. 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 fitting 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 preventative 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.
Roberts Oxygen Company, Inc.
PO Box 5507 Rockville, MD 20855
301-948-8100

OXYGEN
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:46123-001
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	990 mL in 1 L

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46123-001-01	170 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
2	NDC:46123-001-02	181 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
3	NDC:46123-001-03	246 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
4	NDC:46123-001-04	425 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
5	NDC:46123-001-05	587 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
6	NDC:46123-001-06	651 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
7	NDC:46123-001-07	705 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
8	NDC:46123-001-08	1048 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
9	NDC:46123-001-09	3993 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
10	NDC:46123-001-10	7986 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
11	NDC:46123-001-11	9346 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
12	NDC:46123-001-12	4163 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
13	NDC:46123-001-13	212 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
14	NDC:46123-001-14	34 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
15	NDC:46123-001-15	112147 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205849	01/01/1967

Labeler - Roberts Oxygen Company, Inc. (042646877)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		020325953	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		037669104	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		094888112	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		116950907	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		121820476	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		783854045	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		788511095	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		791818008	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		926687468	manufacture(46123-001)

Name	Address	ID/FEI	Business Operations
Establishment
Roberts Oxygen Company, Inc.		959266628	manufacture(46123-001)