Reconstituted Air by Helget Gas Products / Helget Gas Products, Inc. RECONSTITUTED AIR gas

Reconstituted Air by

Drug Labeling and Warnings

Reconstituted Air by is a Prescription medication manufactured, distributed, or labeled by Helget Gas Products, Helget Gas Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

AIR, COMPRESSED USP

UN1002

DO NOT REMOVE THIS LABEL

Medical Air, USP

Rx only. WARNING: 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. Obtain, read and follow all safety instructions before use. Use a back flow preventive device in the piping. Mixture of Oxygen USP and Nitrogen NF. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. 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.

HELGET GAS PRODUCTS, 4211 S. 102ND STREET, OMAHA, NE 68127 866-814-1554

INGREDIENTS AND APPEARANCE

RECONSTITUTED AIR 
reconstituted air gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52086-020
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	230.5 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52086-020-01	665 L in 1 CYLINDER; Type 0: Not a Combination Product	11/12/2025
2	NDC: 52086-020-02	6032 L in 1 CYLINDER; Type 0: Not a Combination Product	11/12/2025
3	NDC: 52086-020-03	8070 L in 1 CYLINDER; Type 0: Not a Combination Product	11/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205889	11/12/2025

Labeler - Helget Gas Products (109096339)

Establishment
Name	Address	ID/FEI	Business Operations
Helget Gas Products, Inc.		118377644	manufacture(52086-020)