Label: MEDICAL OXYGEN COMPRESSED- oxygen gas
- NDC Code(s): 19979-000-16, 19979-000-65, 19979-000-85, 19979-000-99
- Packager: Dickinson Home Medical Equipment
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
WARNING:
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. CAUTION: Federal law prohibits dispensing without prescription. 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. Prouduced by Air Liquefaction. WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation.Use only with equipement cleaned for oxygen service and rated for cylinder pressure. Use a back flowpreventive device in the piping. Close Valve after each use and when empty. Cylinder temperature should notexceed 52°C (125°F).Use in accordance with the Material Safety Data Sheet (MS DS).
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
MEDICAL OXYGEN COMPRESSED
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:19979-000 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 1 L in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:19979-000-65 165 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2006 2 NDC:19979-000-16 416 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2006 3 NDC:19979-000-85 685 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2006 4 NDC:19979-000-99 1699 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206023 02/01/2006 Labeler - Dickinson Home Medical Equipment (078752225) Establishment Name Address ID/FEI Business Operations Dickinson Home Medical Equipment 078752225 label(19979-000) , transfill(19979-000)
