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Oxygen

oxygen

Approved
Approval ID

9af2a134-4883-5acd-e053-2995a90a0290

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2021

Manufacturers
FDA

J & M CYLINDER GASES, INC.

DUNS: 006977941

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Oxygen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63862-011
Application NumberNDA205865
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxygen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 5, 2021
FDA Product Classification

INGREDIENTS (1)

OXYGENActive
Quantity: 995 mL in 1 L
Code: S88TT14065
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/2/2018

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.

J & M Cylinder Gases, Inc.

Because Contents Count

1702 FIFTH STREET NW

DECATUR, AL 35601

(256) 355-2426 oxygen

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Oxygen - FDA Drug Approval Details