Oxygen

Manufacturer
Rotech Healthcare Inc | ROTECH | RHEMA MEDICAL | Oxygen Plus, Inc. dba Summit Respiratory | HEARTLAND HOME HEALTH CARE | MAJOR MEDICAL | COMMUNITY HOME OXYGEN | ROTECH HOME MEDICAL CARE | FIRST CARE | ROTECH OF ARLINGTON HEIGHTS | MAJOR MEDICAL SUPPLY | KELLEY'S HOME HEALTH SERVICES | G&G MEDICAL | SUMMIT RESPIRATORY | CPO2 | HOME CARE MEDICAL SERVICES | Sentry Home Health | ROTH MEDICAL | CAMBRIA MEDICAL SUPPLY | HOME MEDICAL SYSTEMS | FAMILY HOME CARE | GREAT LAKES HOME MEDICAL | MED-AIR TRANSFILL | VITALCARE HEALTH SERVICES
Effective date
2022-06-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:59:16

Label at a glance#

ProductOxygen
Active ingredientOXYGEN
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.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. 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. oxygen oneoxygen one

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYGEN, REFRIGERATED LIQUID USP

UN1073

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 be establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

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 IGNITION 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 well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop the flow of oxygen 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 oxygen twooxygen two

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57439-003-012025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-022025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-032025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-042025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-052025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-062025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-072025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-082025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-092025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-102025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-112025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-122025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-132025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-142025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-152025-02-01C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-012023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-022023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-032023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-042023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-052023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-062023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-072023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-082023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-092023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-102023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-112023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-122023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-132023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-142023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen
57439-003-152023-07-28C16284748780-10191ceaa-6732-198a-e063-dbdaa90aec3eOxygen

Products#

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NDC Codes#

Ingredients#

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Name, UNII, Kind table
NameUNIIKind
OXYGENS88TT14065ACTIB

Source Document#

Source XML

Orange Book application contexts#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2d0433c9-8f84-17a1-e063-6394a90acb88e17eb920-f035-6530-e053-2995a90a798e2025-01-31Exact identifier
spl set id: e17eb920-f035-6530-e053-2995a90a798e

Reported adverse events (FAERS/openFDA)#

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