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Compressed Gas Oxidizing, N.O.S.: Package Insert / Prescribing Info

Package insert / product label
Generic name: carbon dioxide oxygen mixture
Dosage form: gas

Warnings and Precautions

WARNING: Administration of this 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.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY INCREASE RESPIRATION AND HEART RATE. 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. Use a back flow preventive device in the piping. In case of fire: Stop leak if safe to do so. 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.

FIRST AID: IF ACCIDENTLY INHALED: Remove person to fresh air and keep comfortable breathing. Get medical advice/attention.

CO2-O2 Mix Label

Linde

COMPRESSED GAS, OXIDIZING, N.O.S.
(CARBON DIOXIDE, OXYGEN)

UN3156
CAS 124-38-9
CAS 7782-44-7

2

5.1

Rx only
MEDICAL GAS

_______% CARBON DIOXIDE USP
_______% OXYGEN USP
MIXTURE (NOT FOR CALIBRATION PURPOSES)

FOR MIXTURES GREATER THAN 23.5% OXYGEN.
Component concentrations in mol%.*


_________________ PSI @ 70°F _________________ LITERS




DO NOT REMOVE THIS PRODUCT LABEL.

Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427

SGM001G

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARBON DIOXIDE AND OXYGEN MIXTURE, COMPRESSED, OXIDIZING, N.O.S.
oxygen, carbon dioxide gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25373-011
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen95 L in 100 L
Carbon Dioxide (UNII: 142M471B3J) (Carbon Dioxide - UNII:142M471B3J) Carbon Dioxide5 L in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25373-011-06400 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
2NDC:25373-011-07660 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
3NDC:25373-011-086000 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
4NDC:25373-011-093000 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
5NDC:25373-011-055300 L in 1 CYLINDER; Type 6: Drug/Biologic Combination06/24/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas06/24/1998
Labeler - Linde Gas & Equipment Inc. (805568339)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas & Equipment Inc.010263301manufacture(25373-011)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas & Equipment Inc.016271697manufacture(25373-011)