MedPath
FDA Approval

Oxygen

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
October 10, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Oxygen(997 mL in 1 L)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

ROBINSON`S INDUSTRIAL GAS & EQUIPMENT CORP.

ROBINSON`S INDUSTRIAL GAS & EQUIPMENT CORP.

798062246

Products1

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

Oxygen

Product Details

NDC Product Code
66487-001
Application Number
NDA205840
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
October 10, 2023
OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 997 mL in 1 L

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP UN1072 PRODUCED BY AIR LIQUIFACTION 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. 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 INTENCIFY FIRE; OXYDIZER. 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
ROBINSON’S INDUSTRIAL GAS & EQUIPMENT CORP. 920 LINCOLN AVENUE, SUITE 14 . HOLBROOK, NY 11741 (631) 289-1982 oxygen one


© Copyright 2025. All Rights Reserved by MedPath