OXYGEN- oxygen gas 
Gammie HomeCare, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Oxygen, USP

Principal for Oxygen Product

RepresentativeHPLabel

OXYGEN

COMPRESSED

USP

UN 1072

PRODUCED BY AIR LIQUIFICATION

WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

WARNING: Federal law prohibits dispensing without prescription. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjuction with resuscitative equipment.

WARNING: Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.

USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

DO NOT REMOVE THIS PRODUCT LABEL.

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60268-0001
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60268-0001-2255 L in 1 CYLINDER; Type 0: Not a Combination Product05/09/2017
2NDC:60268-0001-3425 L in 1 CYLINDER; Type 0: Not a Combination Product05/09/2017
3NDC:60268-0001-4680 L in 1 CYLINDER; Type 0: Not a Combination Product05/09/2017
4NDC:60268-0001-1170 L in 1 CYLINDER; Type 0: Not a Combination Product05/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas05/09/201712/31/2020
Labeler - Gammie HomeCare, Inc. (157773532)

Revised: 12/2020
Document Id: b78a0d7c-1fe9-2735-e053-2a95a90a0f64
Set id: a8437fbc-5e33-4c56-a64f-0413d2f28986
Version: 4
Effective Time: 20201228
 
Gammie HomeCare, Inc.