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Animal NDC 66365-011-10 Oxygen

Animal Product Information

Field Name Field Value
Animal NDC Code 66365-011-10
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 Medical Comfort Systems 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 NADA141387 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



Package Label.Principal Display Panel



PRODUCED BY AIR LIQUEFACTION
OXYGEN, COMPRESSED USP
UN 1072
DO NOT REMOVE THIS PRODUCT LABEL
DANGER:
COMPRESSED, OXIDIZING GAS, MAY CAUSE OR INTENSIFY FIRE, OXIDIZER, CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED
NO SMOKING
NO VAPING
NO OPEN FLAME
Federal law requires that this container be filled with oxygen USP only by establishments registered as a drug producer in accordance with the Federal food, drug and cosmetics act. Keep out of reach of children. Do not use or store near heat or open flame.
WARNING: HIGH PRESSURE, OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION.
NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.
Keep oil and grease away. Open valve slowly. Store and use with adequate pressure.
Use only with equipment cleaned for oxygen service and rated for cylinder pressure.
Use a back flow preventive device in the piping.
Close valve after each use and when empty. Cylinder temperature should not exceed 52 C (125 F).
Use in accordance with Safety Data Sheet (SDS)
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical application, Rx Required. 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.
CAS NO: 7782-7 E 682 Liters
M6/B 165 Liters M 3458 Liters
M9/C 248 Liters M60 1738 Liters
D 415 Liters Other Liters
Medical Comfort Systems
112-A White Oak Lane
Lexington, SC 29073
(800) 765-4697


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.