OXYGEN- oxygen gas 
Anaconda Oxygen & Respiratory Specialists Inc dba Anaconda Oxygen Service

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

Representative Label

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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:18087-0001
Route of Administration RESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L  in 100 L
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:18087-0001-2 248 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2018
2 NDC:18087-0001-3 165 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2018
3 NDC:18087-0001-1 682 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2018
4 NDC:18087-0001-4 425 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2018
5 NDC:18087-0001-5 113 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2018
6 NDC:18087-0001-6 7080 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 09/01/2018
Labeler - Anaconda Oxygen & Respiratory Specialists Inc dba Anaconda Oxygen Service (879399731)
Registrant - Anaconda Oxygen & Respiratory Specialists Inc dba Anaconda Oxygen Service (879399731)
Establishment
Name Address ID/FEI Business Operations
Anaconda Oxygen & Respiratory Specialists Inc dba Anaconda Oxygen Service 879399731 manufacture(18087-0001)

Revised: 10/2018
Document Id: 78836bab-10ce-347d-e053-2991aa0a6293
Set id: 5c319c6e-c089-49ec-9470-2126d2a99962
Version: 3
Effective Time: 20181018
 
Anaconda Oxygen & Respiratory Specialists Inc dba Anaconda Oxygen Service