reconstituted Air by AMERICAN WELDING & GAS, INC. RECONSTITUTED AIR gas

reconstituted Air by

Drug Labeling and Warnings

reconstituted Air by is a Prescription medication manufactured, distributed, or labeled by AMERICAN WELDING & GAS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

AIR, COMPRESSED

UN1002

MEDICAL AIR, USP

WARNING: For breathing support when used by properly trained personnel. For medical applications, RX only. Administration of Medical Air 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 Medical Air 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. WARNING: CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED. SUPPORTS COMBUSTION. Do not handle until all safety precautions have been read and understood. Use a back flow preventive device in the piping. Mixture of oxygen USP and nitrogen NF. Use only equipment of compatible materials of construction and rated for cylinder pressure. 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: 132259-10-0 DO NOT REMOVE THIS PRODUCT LABEL.

American Welding & Gas, Inc.

4900 Falls of Neuse Road, Suite 150

Raleigh, NC 27609

800-967-6874

INGREDIENTS AND APPEARANCE

RECONSTITUTED AIR 
reconstituted air gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 44076-107
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	210 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
NITROGEN (UNII: N762921K75)	790 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44076-107-01	8807 L in 1 CYLINDER; Type 0: Not a Combination Product	02/13/2019
2	NDC: 44076-107-02	6598 L in 1 CYLINDER; Type 0: Not a Combination Product	02/13/2019
3	NDC: 44076-107-03	665 L in 1 CYLINDER; Type 0: Not a Combination Product	02/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205865	02/13/2019

Labeler - AMERICAN WELDING & GAS, INC. (068181965)

Establishment
Name	Address	ID/FEI	Business Operations
AMERICAN WELDING & GAS, INC.		829720098	manufacture(44076-107)