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FDA Approval

Helium Oxygen mixture

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

FDA Approval Summary

Company
Effective Date
January 19, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Oxygen(200 mL in 1 L)
Helium(800 mL in 1 L)

Manufacturing Establishments2

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

Praxair Distribution, Inc

Praxair Distribution, Inc.

161317490

Praxair Distribution, Inc.

Praxair Distribution, Inc.

045252439

Products1

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

Helium Oxygen mixture

Product Details

NDC Product Code
59579-009
Application Number
NDA205851
Marketing Category
NDA authorized generic (C73605)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 19, 2023
OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 200 mL in 1 L
HeliumActive
Code: 206GF3GB41Class: ACTIBQuantity: 800 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

UN3156

COMPRESSED GAS,

OXIDIZING, N.O.S.

(OXYGEN, HELIUM)

% HELIUM USP CAS: 7440-59-7

% OXYGEN USP CAS: 7782-44-7

NET CONTENTS

LOT NUMBER

WARNING! HIGH-PRESSURE, OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION.

Keep oil, grease, and combustibles away. Store and use with adequate ventilation. Use only with equipment rated for cylinder pressure and cleaned for oxygen service. Cylinder temperature should not exceed 125°F (52°C). Open valve slowly. Close valve after each use; keep closed even when empty. Always secure cylinder. Install cap, if provided, when not in use. Use a backflow prevention device in any piping. Use per MSDS provided and Praxair safety booklets P-3499 and P-14-153. Obtain from your local supplier.

FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, qualified personnel may give oxygen. Call a physician.

RX ONLY

WARNING! Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed

practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods and

frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken.

Rx only IN CASE OF EMERGENCY CALL 1-800-645-4633

Copyright 1997-1998, 2003, 2005 Praxair Technology, Inc.

DO NOT REMOVE THIS LABEL MMG-3-0 (10/05)

Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113 label two


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