NDC | 11043-001-01, 11043-001-02, 11043-001-03, 11043-001-04, 11043-001-05, 11043-001-06, 11043-001-07, 11043-001-08 |
Set ID | 89544705-5d9d-4595-8870-fa46c9c14af2 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | S. J. Smith Co., Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NDA205767 |
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PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
UN1072
PRODUCED BY AIR LIQUEFACTION
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. Keep out of reach of children. 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: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. 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.
S.J. SMITH CO.
3707 WEST RIVE DR. DAVENPORT, IA 52802
563-324-5237
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PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
UN1072
PRODUCED BY AIR LIQUEFACTION
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. Keep out of reach of children. 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: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. 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.
S.J. SMITH CO.
3707 WEST RIVE DR. DAVENPORT, IA 52802
563-324-5237
-
PRINCIPAL DISPLAY PANEL
OXYGEN, REFRIGERATED LIQUID USP
UN1073
145692 LTRS:
CONTENTS: CU FT:
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. Keep out of reach of children. 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.
Produced by Air Liquefaction.
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 IGINITION 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.
CAS: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
S.J. SMITH CO.
3707 WEST RIVE DR. DAVENPORT, IA 52802
563-324-5237
-
PRINCIPAL DISPLAY PANEL
OXYGEN, REFRIGERATED LIQUID USP
UN1073
145692 LTRS:
CONTENTS: CU FT:
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. Keep out of reach of children. 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.
Produced by Air Liquefaction.
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 IGINITION 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.
CAS: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
S.J. SMITH CO.
3707 WEST RIVE DR. DAVENPORT, IA 52802
563-324-5237
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11043-001 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:11043-001-01 154326 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1986 2 NDC:11043-001-02 7107 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1986 3 NDC:11043-001-03 3539 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1986 4 NDC:11043-001-04 651 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1986 5 NDC:11043-001-05 396 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1986 6 NDC:11043-001-06 141 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1986 7 NDC:11043-001-07 127425 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1986 8 NDC:11043-001-08 145692 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1986 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205767 01/01/1986 Labeler - S. J. Smith Co., Inc. (170279462) Establishment Name Address ID/FEI Business Operations S. J. Smith Co., Inc. 022100119 manufacture(11043-001) Establishment Name Address ID/FEI Business Operations S. J. Smith Co., Inc. 098385813 manufacture(11043-001) Establishment Name Address ID/FEI Business Operations S. J. Smith Co., Inc. 170279462 manufacture(11043-001) Establishment Name Address ID/FEI Business Operations S. J. Smith Co., Inc. 170279702 manufacture(11043-001) Establishment Name Address ID/FEI Business Operations S. J. Smith Co., Inc. 612212936 manufacture(11043-001)