Animal NDC 49496-011-38 Oxygen

Animal Product Information

Field Name Field Value
Animal NDC Code 49496-011-38
Proprietary Name Oxygen What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Oxygen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name American Compressed Gases Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Oxygen
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141354 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Oxygen Images

Oxygen Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Oxygen, Compressed



OXYGEN, COMPRESSED USP
UN 1072

WARNING:  For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.  For all other medical applications, Rx only.  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 conjunction with resuscitative equipment.  Produced by Air Liquefaction.  WARNING: HIGH PRESSURE OXIDIZING GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  Keep oil and grease away.  Open valve slowly.  Store and use with adequate ventilation.  Use only with equipment cleaned for Oxygen service and rated for cylinder pressure.  Use a backflow preventive device in the piping.  Close valve after each use and when empty.  Cylinder temperature should not exceed 52oC (125oF).  Use in accordance with the Material Safety Data Sheet (MSDS).

CAS:7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL

AMERICAN COMPRESSED GASES, INC.
NEW YORK CITY, NY (718) 392-9800  .  WEST/BRONX, NY (914) 968-8708
ROCKLAND (845) 623-8066  .  LONG ISLAND, NY (516) 935-4700
BRANFORD, CT (203) 483-7772

17033  (R 04/05)

CONTENTS:  LTRS._____   CU.FT. _____


Oxygen, Refrigerated Liquid



OXYGEN, REFRIGERATED LIQUID USP
UN 1073

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

WARNING:  For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.  For all other medical applications, Rx only.
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 conjunction with resuscitative equipment.  
Produced by Air Liquefaction.  
WARNING: EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.
Keep oil, grease, and combustibles away.  Use only with equipment cleaned for oxygen service. Store and use with adequate ventilation.  Do not get liquid in eyes, on skin, or clothing.  For liquid withdrawal, wear face shield and gloves.  Do not drop.  Use suitable hand truck for container movement.  Avoid spills.  Do not walk on or roll equipment over spills.  Cylinder temperature should not exceed 52oC (125oF).  Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS).
FIRST AID: IN CASE OF FROSTBITE, obtain medical treatment immediately.    

CAS:7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL

AMERICAN COMPRESSED GASES, INC.
34-52 LAUREL HILL BLVD.
MASPETH, NY 11378
(718) 392-9800

47136  (10/00)


Oxygen, Certificate Of Analysis



CERTIFICATE OF ANALYSIS       Facility No.                 Ref. SOP 16.03, 16.07, 16.11
Product: Oxygen, USP        American Compressed Gases, Inc.    34-52 Laurel Hill Blvd.   Maspeth, NY  11378-2007
Serial No.__________
Lot No. __________
Produced by Air Liquefaction
[  ]  Bulk storage vessel   [  ]  Vehicle-mounted vessel   [  ]  DOT 4L portable cylinder   [  ]  Home cryogenic vessel   [  ]  High-pressure cylinder

ANALYZE   SPECIFICATION   RESULTS       ANALYTICAL METHOD               ANALYZER
Odor               None                          _______         Olfaction (smell)
ID                   Oxygen                      _______         Paramagnetic Oxygen analyzer
Assay             >99.2                         _______

Analyst   ____________   Date:_______
“This is to certify that I have been trained in the vendor’s analytical methodology and have witnessed the analysis of this lot of drug product”
Witnessed: ____________ (Customer representative)   Date: _______
Company:_____________
Remarks:


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