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Helium Oxygen mixture

Helium Oxygen Mixture

Approved
Approval ID

ef29f856-4675-4bb7-adef-67d7c6f27439

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 19, 2023

Manufacturers
FDA

Praxair Distribution, Inc.

DUNS: 042845636

Products 1

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

Helium Oxygen mixture

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59579-009
Application NumberNDA205851
Product Classification
M
Marketing Category
C73605
G
Generic Name
Helium Oxygen mixture
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 19, 2023
FDA Product Classification

INGREDIENTS (2)

OXYGENActive
Quantity: 200 mL in 1 L
Code: S88TT14065
Classification: ACTIB
HELIUMActive
Quantity: 800 mL in 1 L
Code: 206GF3GB41
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/21/2019

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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Helium Oxygen mixture - FDA Drug Approval Details