Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 12201-001-01, 12201-001-02, 12201-001-03, 12201-001-04, view more12201-001-05, 12201-001-06 - Packager: CENTRAL NEBRASKA HOME CARE SERVICES
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 27, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
OXYGEN, REFRIGERATED LIQUID USP
UN1073
Produced by Air Liquefaction
CAS 7782-44-7
FOR CHEMICAL EMERGENCY
CALL CHEM-TREC 1-800-424-9300
Manufactured by:
Central Nebraska Home Care
Live. Right. Now.
Central Nebraska Home Care
221 W. 44th Street
Kearney, NE 68845
308-865-2711
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. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.
Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug And Cosmetic Act.
DANGER:
KEEP OUT OF REACH OF CHILDREN.
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.
FIRST AID:
IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
DO NOT REMOVE THIS PRODUCT LABEL.
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12201-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 210 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12201-001-01 37619 L in 1 DEWAR; Type 0: Not a Combination Product 03/01/2013 2 NDC:12201-001-02 33756 L in 1 DEWAR; Type 0: Not a Combination Product 03/01/2013 3 NDC:12201-001-03 29069 L in 1 DEWAR; Type 0: Not a Combination Product 03/01/2013 4 NDC:12201-001-04 25523 L in 1 DEWAR; Type 0: Not a Combination Product 03/01/2013 5 NDC:12201-001-05 17290 L in 1 DEWAR; Type 0: Not a Combination Product 03/01/2013 6 NDC:12201-001-06 1 L in 1 DEWAR; Type 0: Not a Combination Product 03/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206023 03/01/2013 Labeler - CENTRAL NEBRASKA HOME CARE SERVICES (122017783) Establishment Name Address ID/FEI Business Operations CENTRAL NEBRASKA HOME CARE SERVICES 122017783 manufacture(12201-001)