Label: OXYGEN- oxygen gas
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Contains inactivated NDC Code(s)
NDC Code(s): 25373-101-07, 25373-101-08, 25373-101-09, 25373-101-10 - Packager: Linde Gas & Equipment Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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.
Drug Label Information
Updated December 14, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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WARNINGS SECTION
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other 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.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER.
CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY.
COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.
Do not handle until all safety precautions have been read and understood.
Keep and store away from clothing and other combustible materials.
Keep valves and fittings free from grease and oil.
Use and store only outdoors or in a well-ventilated place.
Wear cold insulating gloves, face shield, and eye protection.
In case of fire: Stop leak if safe to do so.
Use a back flow preventive device in the piping.
Use only with equipment of compatible materials of construction and rated for cylinder pressure.
Use only with equipment cleaned for oxygen service.
DO NOT change or force fit connections.
Avoid spills. Do not walk on or roll equipment over spills.
Close valve after each use and when empty.
Always keep container in upright position.
Read and follow the Safety Data Sheet (SDS) before use.
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Un-Coded Section
FIRST AID
IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug producer in accordance with the Federal Food, Drug, and Cosmetic Act. KEEP OUT OF REACH OF CHILDREN.
DO NOT REMOVE THIS LABEL.
CONTENTS: CYLINDER TYPE LITERS 160L [_] 121703 180L [_] 131617 200L [_] 143924 230L [_] 167855 _____ _____ _____ Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427
LG012F
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25373-101 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:25373-101-07 121703 L in 1 DEWAR; Type 0: Not a Combination Product 06/16/1986 2 NDC:25373-101-08 131617 L in 1 DEWAR; Type 0: Not a Combination Product 06/16/1986 3 NDC:25373-101-09 143924 L in 1 DEWAR; Type 0: Not a Combination Product 06/16/1986 4 NDC:25373-101-10 167855 L in 1 DEWAR; Type 0: Not a Combination Product 06/16/1986 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 06/16/1986 Labeler - Linde Gas & Equipment Inc. (805568339) Registrant - Linde Gas & Equipment Inc. (805568339) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 010263301 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 016271697 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 833132561 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 063018874 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 069239874 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 784579190 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 805823411 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 016300933 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 164139060 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 026921048 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 129012352 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 142591424 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 168248081 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 067906953 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 789082976 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 149324605 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 833120244 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 833120723 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 134971428 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 181444840 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 839176356 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 069232473 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 160443631 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 833132108 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 080006834 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 019551467 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 078692645 manufacture(25373-101) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 080428082 manufacture(25373-101)
