Oxygen Gas
FDA Label NDC 12121-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Badger Welding Supplies, Inc. for the product Oxygen (NDC 12121-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding oxygen compressed usp label, oxygen refrigerated liquid usp label, oxygen certificate of analysis, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Oxygen Compressed Usp Label

OXYGEN COMPRESSED USP

UN 1072

PRODUCED BY AIR LIQUEFACTION

OXYGEN 2

17033 (12/14)

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 oxgen 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 it is 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 manufacture 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. 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

BADGER WELDING SUPPLIES, INC.
101 SOUTH DICKSON STREET  MADISON WI 53703

608-257-5606

CONTENTS:     CU. FT. _______________  LTRS. __________

Oxygen Refrigerated Liquid Usp Label

REFIGERATED LIQUID

OXYGEN REFRIGERATED LIQUID USP

 UN 1073

OXYGEN 2

CONTENTS: _____________________________________LTRS: ______________ CU. FT: _______________________

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 oxgen 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 it is 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 manufacture in accordance with the Federal Food, Drug and Cosmetic Act.

Produced by Air Liquefaction.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFIGERATED 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 a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. 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. DO NOT change or force fit connections. Avoid spills. Do not walk 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 advise/attention. 

CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL

BADGER WELDING SUPPLIES, INC.
101 SOUTH DICKSON STREET • MADISON, WI 53703

608-257-5606

47136 (03/17)

Oxygen Certificate Of Analysis

THIS LETTER IS TO PROVIDE YOU WITH THE CERTIFICATION YOU REQUESTED FOR OXYGEN USP, LOT _____________ SUPPLIED TO YOU IN CYLINDERS / VESSELS BY OUR LOCATION.  THESE CYLINDERS WERE FILLED IN ACCORDANCE WITH THE STANDARD OPERATING PROCEDURES UTILIZED FOR THE MANUFACTURE OF MEDICAL GASES.  BY FOLLOWING THESE PROCEDURES, OR LOCATION ENSURES THAT PRODUCTS ARE SAFELY MANUFACTURED IN COMPLIANCE WITH FDA'S CURRENT GOOD MANUFACTURING PRACTICES (cGMP) REGULATIONS AND FDA MEDICAL GAS GUIDELINES.  CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84.  THIS CERTIFICATION DOES NOT ELIMINATE CUSTOMER'S OBLIGATION TO COMPLY WITH OTHER PORTIONS OF 21 CFR 210 AND 211 INCLUDING BY NOT LIMITED TO 21 CFR 211.265 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND VESSELS FILLED FROM THESE SUPPLY CYLINDERS.  THESE CYLINDERS ARE NOT CERTIFIED FOR INSTRUMENT CALIBRATION PURPOSES.

TEST / REQUIREMENT                        NF SPECIFICATION                    LOT ANALYSIS

IDENTIFICATION                                        PASS

ODOR                                                            NO APPRECIABLE ODOR
CARBON DIOXIDE                                          LESS THAN 0.03%

CARBON MONOXIDE                                LESS THAN OR EQUAL TO 0.001%

ASSAY                                                            GREATER THAN OR EQUAL TO 99.0%

THE METHODOLOGY BEING USED TO PERFORM THE USP / NF TEST FOR ASSAY IS INDICATED BELOW: _____________ PARAMAGNETIC ANALYZER MODEL #________________________  _________________________ THIS METHOD IS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP ORSAT METHOD FOR OXYGEN ASSAY. __________________ ORSAT  SUPPLIER SIGNATURE ____________________ DATE _______________

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