Oxygen by Dale Oxygen And Acetylene Service, Inc OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Dale Oxygen And Acetylene Service, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

REFRIGERATED LIQUID
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 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.
Produced by Air Liquefaction.
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 IGINITION 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 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
DALE OXYGEN, INC.
146 HORNER ST. JOHNSTOWN, PA 15902
814-535-3594

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. 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.
DALE OXYGEN, INC.
146 HORNER ST. JOHNSTOWN, PA 15902
814-535-3594

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53452-001
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: 53452-001-01	420 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1963
2	NDC: 53452-001-02	690 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1963
3	NDC: 53452-001-03	3160 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1963
4	NDC: 53452-001-04	6900 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1963
5	NDC: 53452-001-05	165 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1963
6	NDC: 53452-001-06	249 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1963
7	NDC: 53452-001-07	210 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1963
8	NDC: 53452-001-08	2265 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1963
9	NDC: 53452-001-09	200 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1963
10	NDC: 53452-001-10	80 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1963
11	NDC: 53452-001-11	30 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205767	01/01/1963

Labeler - Dale Oxygen And Acetylene Service, Inc (014256960)

Establishment
Name	Address	ID/FEI	Business Operations
Dale Oxygen And Acetylene Service, Inc		014256960	manufacture(53452-001)