Label: OXYGEN gas
- NDC Code(s): 81681-001-01, 81681-001-02, 81681-001-03, 81681-001-04
- Packager: WEST PENN LACO, INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated May 3, 2021
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PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
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. Produced by Air Liquefaction. 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.
WHEN EMPTY RETURN TO: WEST PENN LACO, IN.
1830 LIVERPOOL ST. PITTSBURGH, PA 15233
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81681-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 998 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81681-001-01 424.75 L in 1 CYLINDER; Type 0: Not a Combination Product 03/09/2021 2 NDC:81681-001-02 622.97 L in 1 CYLINDER; Type 0: Not a Combination Product 03/09/2021 3 NDC:81681-001-03 3539.61 L in 1 CYLINDER; Type 0: Not a Combination Product 03/09/2021 4 NDC:81681-001-04 7101.53 L in 1 CYLINDER; Type 0: Not a Combination Product 03/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205767 03/09/2021 Labeler - WEST PENN LACO, INC. (015028152) Establishment Name Address ID/FEI Business Operations WEST PENN LACO, INC. 074536780 manufacture(81681-001)