Label: OXYGEN gas
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NDC Code(s):
53663-0001-1,
53663-0001-2,
53663-0001-3,
53663-0001-4, view more53663-0001-5, 53663-0001-6, 53663-0001-7, 53663-0001-8
- Packager: Adventist Health Sonora dba Adventist Health Oxygen & Medical Supply
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 4, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Principal for Oxygen Product
OXYGEN
COMPRESSED
USP
UN 1072
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 NO: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
WARNING: No smoking or vaping. 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.
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53663-0001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53663-0001-1 170 L in 1 CYLINDER; Type 0: Not a Combination Product 12/18/2009 2 NDC:53663-0001-2 682 L in 1 CYLINDER; Type 0: Not a Combination Product 12/18/2009 3 NDC:53663-0001-3 6910 L in 1 CYLINDER; Type 0: Not a Combination Product 12/18/2009 4 NDC:53663-0001-8 8800 L in 1 CYLINDER; Type 0: Not a Combination Product 12/18/2009 12/31/2018 5 NDC:53663-0001-4 415 L in 1 CYLINDER; Type 0: Not a Combination Product 12/18/2009 6 NDC:53663-0001-5 240 L in 1 CYLINDER; Type 0: Not a Combination Product 12/18/2009 12/31/2018 7 NDC:53663-0001-6 623 L in 1 CYLINDER; Type 0: Not a Combination Product 12/18/2009 8 NDC:53663-0001-7 255 L in 1 CYLINDER; Type 0: Not a Combination Product 12/18/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 07/15/1985 Labeler - Adventist Health Sonora dba Adventist Health Oxygen & Medical Supply (094917056) Establishment Name Address ID/FEI Business Operations Adventist Health Sonora dba Adventist Health Oxygen & Medical Supply 094917056 manufacture(53663-0001)