MedPath

Air 90% Carbon Dioxide 10%

Carbon Dioxide 10% Air 90%

Approved
Approval ID

4234d75f-5fbd-49c1-97f6-a8c4d209723b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2021

Manufacturers
FDA

A-OX WELDING SUPPLY CO., INC.

DUNS: 024372385

Products 1

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

Air 90% Carbon Dioxide 10%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10297-004
Application NumberNDA205846
Product Classification
M
Marketing Category
C73594
G
Generic Name
Air 90% Carbon Dioxide 10%
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 5, 2021
FDA Product Classification

INGREDIENTS (3)

OXYGENInactive
Quantity: 189 mL in 1 L
Code: S88TT14065
Classification: IACT
CARBON DIOXIDEActive
Quantity: 100 mL in 1 L
Code: 142M471B3J
Classification: ACTIB
NITROGENInactive
Quantity: 711 mL in 1 L
Code: N762921K75
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/2/2018

Purity Plus Specialty Gases by A-OX Welding Supply NON-FLAMMABLE GAS 2 Compressed gas, n.o.s. (Carbon Dioxide, Air) UN1956 PPG AIRCD10USPK
Medical Gas Mixture 10% Carbon Dioxide, USP CAS: 124-38-9 Balance Air, USP CAS: N/A
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.
DANGER: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY INCREASE RESPIRATION AND HEART RATE.
Do not handle until all safety precautions have been read and understood. Avoid breathing gas. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
Lot No: XXX Tag No: XXX DO NOT REMOVE THIS PRODUCT LABEL For Medical Use Only. Ver. 3.76 Volume: 218.6 SCF A-OX Welding Co. 101 N Harlem Ave. Sioux Falls, SD 57104 605.336.1125 air ninety carbon dioxide ten

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Air 90% Carbon Dioxide 10% - FDA Drug Approval Details