Label: RECONSTITUTED AIR gas
- NDC Code(s): 44076-107-01, 44076-107-02, 44076-107-03
- Packager: AMERICAN WELDING & GAS, INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 6, 2023
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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
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INGREDIENTS AND APPEARANCE
RECONSTITUTED AIR
reconstituted air gasProduct 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. 116724243 manufacture(44076-107) Establishment Name Address ID/FEI Business Operations AMERICAN WELDING & GAS, INC. 116933887 manufacture(44076-107) Establishment Name Address ID/FEI Business Operations AMERICAN WELDING & GAS, INC. 829720098 manufacture(44076-107)