Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 70423-001-06 - Packager: DANI Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 1, 2016
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP UN 1072
DANGER:
COMPRESSED. OXIDIZING GAS. MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED.
In case of fire: stop leak if safe to do so. Keep reduction valves free from grease and oil. Open valve slowly. Store and use in a well ventilated place. Use a back flow preventative device in the piping. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 "C/125 °F. Container temperature should not exceed 52 °C/125°F. Do not handle until all safety precautions have been read and understood. Keep/store away from combustible materials. Use only with equipment cleaned for oxygen service and rated for cylinder pressure.
DO NOT REMOVE THIS PRODUCT LABEL.
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. 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. Produced by Air Liquefaction. CAS NO: 7782-44-7
SIZE M6 6SCF/170 Liters
DANI Inc
58 Walker Lane
Newtown, PA 18940-1888 USA
TEL: 1-800-423-1100 FAX: 1-888-4231102
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70423-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70423-001-06 170 L in 1 CYLINDER; Type 0: Not a Combination Product 03/02/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 03/02/2016 Labeler - DANI Inc (079726635) Registrant - DANI Inc (079726635) Establishment Name Address ID/FEI Business Operations DANI Inc 079726635 manufacture(70423-001)