Oxygen by CRYOGENIC SOLUTIONS LLC OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by CRYOGENIC SOLUTIONS LLC. 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 required. 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 away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use 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. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Use only equipment of compatible materials of construction. Open valve slowly. Use only with equipment cleaned for oxygen service. 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.

NO SMOKING

NO VAPING

Cryogenic Solutions, LLC

4305 Saguaro Trail

Indianapolis, IN 46268

317-839-8100

PRINCIPAL DISPLAY PANEL

OXYGEN, REFRIGERATED LIQUID USP

UN1073

WARNING:

For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx required. 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 INTESIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

Obtain, read and follow all safety instructions before use. Keep away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use only outdoors or with adequate ventilation. Store in a well-ventilated place. Wear cold insulating gloves and either face shield or eye protection. 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. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Do no open valve until connected to equipment prepared for use. Open valve slowly. 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 medical help.

DO NOT REMOVE THIS PRODUCT LABEL.

NO SMOKING

NO VAPING

Cryogenic Solutions, LLC

4305 Saguaro Trail Indianapolis, IN 46268

317-839-8100

PRINCIPAL DISPLAY PANEL

OXYGEN, REFRIGERATED LIQUID USP

UN1073

WARNING:

For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx required. 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 INTESIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

Obtain, read and follow all safety instructions before use. Keep away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use only outdoors or with adequate ventilation. Store in a well-ventilated place. Wear cold insulating gloves and either face shield or eye protection. 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. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Do no open valve until connected to equipment prepared for use. Open valve slowly. 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 medical help.

DO NOT REMOVE THIS PRODUCT LABEL.

NO SMOKING

NO VAPING

SAGUARO RESPIRATORY SERVICES

4496 Saguaro Trail Indianapolis, IN 46268

866-583-4747

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 81734-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	995 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81734-001-01	679 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2021
2	NDC: 81734-001-02	425 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2021
3	NDC: 81734-001-03	170 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2021
4	NDC: 81734-001-04	255 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2021	01/30/2024
5	NDC: 81734-001-05	1699 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2021
6	NDC: 81734-001-06	2549 L in 1 CYLINDER; Type 0: Not a Combination Product	09/01/2021	01/30/2024
7	NDC: 81734-001-07	41 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
8	NDC: 81734-001-08	45 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
9	NDC: 81734-001-09	46 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
10	NDC: 81734-001-10	160 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
11	NDC: 81734-001-11	104 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
12	NDC: 81734-001-12	3831 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
13	NDC: 81734-001-13	150 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
14	NDC: 81734-001-14	7842 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
15	NDC: 81734-001-15	586 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2021
16	NDC: 81734-001-16	5678.118 L in 1 TANK; Type 0: Not a Combination Product	08/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205767	08/30/2021

Labeler - CRYOGENIC SOLUTIONS LLC (013491617)

Establishment
Name	Address	ID/FEI	Business Operations
CRYOGENIC SOLUTIONS LLC		013491617	manufacture(81734-001)

Establishment
Name	Address	ID/FEI	Business Operations
Saguaro Respiratory Services LLC		068225138	transfill(81734-001)

Establishment
Name	Address	ID/FEI	Business Operations
Saguaro Respiratory Services LLC		144856071	transfill(81734-001)