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Oxygen

Oxygen

Approved
Approval ID

e42bc80d-47e4-7eeb-e053-2a95a90ac877

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 19, 2022

Manufacturers
FDA

AMERICAN GASES CORPORATION

DUNS: 796515054

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 Code82606-001
Application NumberNDA205767
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxygen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJuly 19, 2022
FDA Product Classification

INGREDIENTS (1)

OXYGENActive
Quantity: 990 mL in 1 L
Code: S88TT14065
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/19/2022

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. 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.

AMERICAN GASES CORP.

2217 NORTH DELANY RD. WAUKEGAN, IL 60087

847-336-4734 oxygen two

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Oxygen - FDA Drug Approval Details