Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 65689-001-01, 65689-001-02, 65689-001-03, 65689-001-04, view more65689-001-05, 65689-001-06, 65689-001-07, 65689-001-08, 65689-001-09, 65689-001-10, 65689-001-11, 65689-001-12, 65689-001-13, 65689-001-14, 65689-001-15, 65689-001-16, 65689-001-17, 65689-001-18, 65689-001-19, 65689-001-20, 65689-001-21, 65689-001-22, 65689-001-23, 65689-001-24, 65689-001-25, 65689-001-26 - Packager: Oxygen One, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 18, 2019
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PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP UN1072 OXYGEN 2
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical application, 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. PRODUCED BY AIR LIQUIFACTION DANGER: MAY CAUSE OR INTENCIFY FIRE; OXYDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. 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. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL
Oxygen One, Inc. 1900 Pewaukee Rd., Suite F, Waukesha, Wi 53188 (262) 521-2202 -
PRINCIPAL DISPLAY PANEL
OXYGEN, REFRIGERATED LIQUID USP UN1073 Rx ONLY OXYGEN 2Rx ONLY.
WARNING: USP 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. Produced by Air Liquefaction.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXYDIZER. 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 sfe to do so. Use a back flow preventive device inthe 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 foll 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. CAS: 7782-44-7
Oxygen One, Inc. 1900 Pewaukee Rd., Suite F, Waukesha, Wi 53188 (262) 521-2202 -
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65689-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 992 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65689-001-01 7075 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 2 NDC:65689-001-02 3575 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 3 NDC:65689-001-03 3450 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 4 NDC:65689-001-04 2549 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 5 NDC:65689-001-05 1725 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 6 NDC:65689-001-06 682 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 7 NDC:65689-001-07 680 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 8 NDC:65689-001-08 415 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 9 NDC:65689-001-09 515 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 10 NDC:65689-001-10 240 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 11 NDC:65689-001-11 164 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 12 NDC:65689-001-12 113 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 13 NDC:65689-001-13 165 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 14 NDC:65689-001-14 255 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 15 NDC:65689-001-15 10 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 16 NDC:65689-001-16 20 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 17 NDC:65689-001-17 30 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 18 NDC:65689-001-18 45 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 19 NDC:65689-001-19 60 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 20 NDC:65689-001-20 21 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 21 NDC:65689-001-21 31 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 22 NDC:65689-001-22 36 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 23 NDC:65689-001-23 41 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 24 NDC:65689-001-24 60 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 25 NDC:65689-001-25 1134 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 26 NDC:65689-001-26 726 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205889 01/01/1999 Labeler - Oxygen One, Inc. (118987911) Establishment Name Address ID/FEI Business Operations Oxygen One, Inc. 118987911 manufacture(65689-001)