NDC Code(s) : 12213-800-14, 12213-800-58, 12213-800-01, 12213-800-02, 12213-800-03, 12213-800-04, 12213-800-05, 12213-800-06
Packager : NEXAIR, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Carbon Dioxide/Oxygen MixCarbon Dioxide/Oxygen Mix GAS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12213-800
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYGEN(UNII: S88TT14065)
(OXYGEN - UNII:S88TT14065) 		OXYGEN50 mL in 1 L
Inactive Ingredients
Ingredient Name Strength
CARBON DIOXIDE(UNII: 142M471B3J)950 mL in 1 L
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:12213-800-146400 L in 1 CYLINDER Type 0: Not a Combination Product06/01/1996
2NDC:12213-800-58708 L in 1 CYLINDER Type 0: Not a Combination Product06/01/1996
3NDC:12213-800-016405 L in 1 CYLINDER Type 0: Not a Combination Product06/01/1996
4NDC:12213-800-026374 L in 1 CYLINDER Type 0: Not a Combination Product06/01/1996
5NDC:12213-800-03586 L in 1 CYLINDER Type 0: Not a Combination Product06/01/1996
6NDC:12213-800-04705 L in 1 CYLINDER Type 0: Not a Combination Product06/01/1996
7NDC:12213-800-05645.5 L in 1 CYLINDER Type 0: Not a Combination Product06/01/1996
8NDC:12213-800-066020 L in 1 CYLINDER Type 0: Not a Combination Product06/01/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205849 06/01/1996

LABELER - NEXAIR, LLC(927024422)

Establishment
Name Address ID/FEI Business Operations
NEXAIR, LLC 010263301 manufacture(12213-800)

Establishment
Name Address ID/FEI Business Operations
NEXAIR, LLC 927024422 manufacture(12213-800)

PRINCIPAL DISPLAY PANEL

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

UN3156

RX only

% CARBON DIOXIDE, USP

% OXYGEN, USP

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: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY INCREASE RESPIRATION AND HEART RATE. MAY CAUSE FROSTBITE. Do not get in eyes, on skin, or on clothing. 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 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.

CAS: OXYGEN 7782-44-7 CARBON DIOXIDE 124-38-9

FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.

NET CONTENTS

Contains Cubic Feet at 70 F and PSIG

DO NOT REMOVE THIS PRODUCT LABEL.

Distributed by nexAir

nexAir, LLC www.nexAir.com

1350 Concourse Ave., Suite 103 Memphis, TN 38104

888-639-2474 carbon oxygen mix