Oxygen Usp Bulk Liquid

Oxygen Usp Bulk Liquid
SPL v21
SPL
SPL Set ID f20f0ce5-e09e-48c5-8c6e-8e9563f3ce6d
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-01-16
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (99 L)

Identifiers & Packaging

Marketing Status
NDA Active Since 1960-01-01
Description

AIR LIQUIDE  OXYGEN U.S.P.         Form Number: 2A-ALL-QUA-0005-F                                                             Revision:         0                                                             Effective Date: 03/29/06                                                             Page:               1/1 CERTIFICATE OF ANALYSIS Air Liquide large Industries U.S. L.P. – Houston, TX 77056 PRODUCED BY AIR LIQUEFACTION 1.Location       Street Address1                                  2. Carrier ________________ Street Address 2 City, State Zip 3. Lot Number ______________________                4. Trailer No _____________ PRE-FILL REPORT                                                   FILL REPORT 5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate    (>99.5% O 2 )                  Detected                                 loading procedure by:    _______ %                  Yes    No                              Signature _________________________    ________                    ________                             Date _____________________________     Initial                            Initial ANALYSIS REPORT Test required             Method of Analysis                           Specifications                       Results OXYGEN ASSAY       PARAMAGNETIC       ___                  99.5% O 2 Minimum                9. ____%                                     8.Analyzer Tag Number         ODOR                         Organoleptic (Nasal)                           None                                       10. ______ USP applies only when used in a medical application or by medical customers properly registered with the FDA. Note: Oxygen that is produced by the air liquefaction process is exempt from the requirement of the impurity test for Carbon Dioxide and Carbon Monoxide. 11. Analyzed By         ________________________            Date ____________ 12. Witnessed By       ________________________            Date ____________      (only required for HRC customers) 13. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2 14. SQCU Review/Release _______________________     Date ____________ MANDATORY FORM User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.

Medication Information

Description

AIR LIQUIDE  OXYGEN U.S.P.         Form Number: 2A-ALL-QUA-0005-F                                                             Revision:         0                                                             Effective Date: 03/29/06                                                             Page:               1/1 CERTIFICATE OF ANALYSIS Air Liquide large Industries U.S. L.P. – Houston, TX 77056 PRODUCED BY AIR LIQUEFACTION 1.Location       Street Address1                                  2. Carrier ________________ Street Address 2 City, State Zip 3. Lot Number ______________________                4. Trailer No _____________ PRE-FILL REPORT                                                   FILL REPORT 5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate    (>99.5% O 2 )                  Detected                                 loading procedure by:    _______ %                  Yes    No                              Signature _________________________    ________                    ________                             Date _____________________________     Initial                            Initial ANALYSIS REPORT Test required             Method of Analysis                           Specifications                       Results OXYGEN ASSAY       PARAMAGNETIC       ___                  99.5% O 2 Minimum                9. ____%                                     8.Analyzer Tag Number         ODOR                         Organoleptic (Nasal)                           None                                       10. ______ USP applies only when used in a medical application or by medical customers properly registered with the FDA. Note: Oxygen that is produced by the air liquefaction process is exempt from the requirement of the impurity test for Carbon Dioxide and Carbon Monoxide. 11. Analyzed By         ________________________            Date ____________ 12. Witnessed By       ________________________            Date ____________      (only required for HRC customers) 13. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2 14. SQCU Review/Release _______________________     Date ____________ MANDATORY FORM User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.

Oxygen Usp Coa

AIR LIQUIDE  OXYGEN U.S.P.         Form Number: 2A-ALL-QUA-0005-F

                                                            Revision:         0

                                                            Effective Date: 03/29/06

                                                            Page:               1/1

CERTIFICATE OF ANALYSIS

Air Liquide large Industries U.S. L.P. – Houston, TX 77056

PRODUCED BY AIR LIQUEFACTION

1.Location       Street Address1                                  2. Carrier ________________

Street Address 2

City, State Zip

3. Lot Number ______________________                4. Trailer No _____________

PRE-FILL REPORT                                                   FILL REPORT

5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate

   (>99.5% O2)                  Detected                                 loading procedure by:

   _______ %                  Yes    No                              Signature _________________________

   ________                    ________                             Date _____________________________

    Initial                            Initial

ANALYSIS REPORT

Test required             Method of Analysis                           Specifications                       Results

OXYGEN ASSAY       PARAMAGNETIC       ___                  99.5% O2 Minimum                9. ____%

                                    8.Analyzer Tag Number        

ODOR                         Organoleptic (Nasal)                           None                                       10. ______

USP applies only when used in a medical application or by medical customers properly registered with the FDA. Note: Oxygen that is produced by the air liquefaction process is exempt from the requirement of the impurity test for Carbon Dioxide and Carbon Monoxide.

11. Analyzed By         ________________________            Date ____________

12. Witnessed By       ________________________            Date ____________

     (only required for HRC customers)

13. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2

14. SQCU Review/Release _______________________     Date ____________

MANDATORY FORM

User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.

Structured Label Content

Oxygen Usp Coa (Oxygen USP COA)

AIR LIQUIDE  OXYGEN U.S.P.         Form Number: 2A-ALL-QUA-0005-F

                                                            Revision:         0

                                                            Effective Date: 03/29/06

                                                            Page:               1/1

CERTIFICATE OF ANALYSIS

Air Liquide large Industries U.S. L.P. – Houston, TX 77056

PRODUCED BY AIR LIQUEFACTION

1.Location       Street Address1                                  2. Carrier ________________

Street Address 2

City, State Zip

3. Lot Number ______________________                4. Trailer No _____________

PRE-FILL REPORT                                                   FILL REPORT

5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate

   (>99.5% O2)                  Detected                                 loading procedure by:

   _______ %                  Yes    No                              Signature _________________________

   ________                    ________                             Date _____________________________

    Initial                            Initial

ANALYSIS REPORT

Test required             Method of Analysis                           Specifications                       Results

OXYGEN ASSAY       PARAMAGNETIC       ___                  99.5% O2 Minimum                9. ____%

                                    8.Analyzer Tag Number        

ODOR                         Organoleptic (Nasal)                           None                                       10. ______

USP applies only when used in a medical application or by medical customers properly registered with the FDA. Note: Oxygen that is produced by the air liquefaction process is exempt from the requirement of the impurity test for Carbon Dioxide and Carbon Monoxide.

11. Analyzed By         ________________________            Date ____________

12. Witnessed By       ________________________            Date ____________

     (only required for HRC customers)

13. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2

14. SQCU Review/Release _______________________     Date ____________

MANDATORY FORM

User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:45:02.376178 · Updated: 2026-03-14T22:21:43.238921