Oxygen by Rotech Healthcare Inc / ROTECH / RHEMA MEDICAL / Oxygen Plus, Inc. dba Summit Respiratory / HEARTLAND HOME HEALTH CARE / MAJOR MEDICAL / COMMUNITY HOME OXYGEN / ROTECH HOME MEDICAL CARE / FIRST CARE / ROTECH OF ARLINGTON HEIGHTS / MAJOR MEDICAL SUPPLY / KELLEY'S HOME HEALTH SERVICES / G&G MEDICAL / SUMMIT RESPIRATORY / CPO2 / HOME CARE MEDICAL SERVICES / Sentry Home Health / ROTH MEDICAL / CAMBRIA MEDICAL SUPPLY / HOME MEDICAL SYSTEMS / SENTRY HOME HEALTH / FAMILY HOME CARE / GREAT LAKES HOME MEDICAL / MED-AIR TRANSFILL / VITALCARE HEALTH SERVICES OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Rotech Healthcare Inc, ROTECH, RHEMA MEDICAL, Oxygen Plus, Inc. dba Summit Respiratory, HEARTLAND HOME HEALTH CARE, MAJOR MEDICAL, COMMUNITY HOME OXYGEN, ROTECH HOME MEDICAL CARE, FIRST CARE, ROTECH OF ARLINGTON HEIGHTS, MAJOR MEDICAL SUPPLY, KELLEY'S HOME HEALTH SERVICES, G&G MEDICAL, SUMMIT RESPIRATORY, CPO2, HOME CARE MEDICAL SERVICES, Sentry Home Health, ROTH MEDICAL, CAMBRIA MEDICAL SUPPLY, HOME MEDICAL SYSTEMS, SENTRY HOME HEALTH, FAMILY HOME CARE, GREAT LAKES HOME MEDICAL, MED-AIR TRANSFILL, VITALCARE HEALTH SERVICES. 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 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. 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 other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. 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.

PRINCIPAL DISPLAY PANEL

OXYGEN, REFRIGERATED LIQUID USP

UN1073

PRODUCED BY AIR LIQUEFACTION

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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only be establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

DANGER: 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 well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop the flow of oxygen 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. 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 Data Sheet (SDS) before use.

FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention. CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57439-003
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: 57439-003-08	3455 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
2	NDC: 57439-003-09	7100 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
3	NDC: 57439-003-10	9430 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
4	NDC: 57439-003-01	113 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
5	NDC: 57439-003-02	170 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
6	NDC: 57439-003-03	255 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
7	NDC: 57439-003-04	425 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
8	NDC: 57439-003-05	680 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
9	NDC: 57439-003-06	1738 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
10	NDC: 57439-003-07	2549 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2018
11	NDC: 57439-003-11	20 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/2018
12	NDC: 57439-003-12	30 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/2018
13	NDC: 57439-003-13	32 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/2018
14	NDC: 57439-003-14	37 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/2018
15	NDC: 57439-003-15	45 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205889	01/01/2018

Labeler - Rotech Healthcare Inc (144556222)

Registrant - Rotech Healthcare Inc (144556222)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		016953296	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
RHEMA MEDICAL		078670599	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Plus, Inc. dba Summit Respiratory		079569918	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
HEARTLAND HOME HEALTH CARE		079570162	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		079570216	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
MAJOR MEDICAL		079607390	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		079607401	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
COMMUNITY HOME OXYGEN		079607617	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH HOME MEDICAL CARE		079607622	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
FIRST CARE		079639101	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH OF ARLINGTON HEIGHTS		079713679	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		079721579	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
MAJOR MEDICAL SUPPLY		079721904	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		079738728	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
KELLEY'S HOME HEALTH SERVICES		079738768	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
G&G MEDICAL		085400138	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		098136096	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
SUMMIT RESPIRATORY		135922784	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
CPO2		148713329	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		159346050	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
HOME CARE MEDICAL SERVICES		169932436	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
Sentry Home Health		174392501	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTH MEDICAL		179387050	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		611480690	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
CAMBRIA MEDICAL SUPPLY		620007021	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
HOME MEDICAL SYSTEMS		795469142	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
SENTRY HOME HEALTH		796502123	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
G&G MEDICAL		796502479	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTH MEDICAL		831552364	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
SUMMIT RESPIRATORY		831552372	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		831562918	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
FAMILY HOME CARE		831748491	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
GREAT LAKES HOME MEDICAL		831831172	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTECH		833186922	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
MED-AIR TRANSFILL		841973667	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
SUMMIT RESPIRATORY		874476422	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
ROTH MEDICAL		948744180	manufacture(57439-003)

Establishment
Name	Address	ID/FEI	Business Operations
VITALCARE HEALTH SERVICES		956721187	manufacture(57439-003)