FDA.reportPublic FDA data

Carbon Dioxide Oxygen Mixture

Manufacturer
Spec Connection International Inc | Spec Connection Internation, Inc.
Effective date
2024-11-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 21:17:40

Label at a glance#

ProductCarbon Dioxide Oxygen Mixture
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compressed Gas, Oxidizing, N.O.S.,

(Carbon Dioxide, Oxygen)

Medical Gas Mixture

5 percent Carbon Dioxide, USP CAS: 124-38-9

Balance Oxygen, USP CAS: 7782-44-7

CAUTION: Federal law prohibits dispensing without a prescription. RX only.

WARNING: OXIDZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION. CAN INCREASE RESPIRATION AND HEART RATE.

Keep oil and grease away. Cylinder temperature should not exceed 125 F (52 C). Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Do not get in eyes, on skin or clothing. Close valve after each use and when empty. Open valve slowly. Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken. Secure cylinder while in transportation, storage and in use.

SPEC CONNECTION INTERNATION, INC.

37325 STATE ROAD 54 ZEPHYRHILLS, FL 33542

813-997-7646

DO NOT REMOVE THIS PRODUCT LABEL co2 o2 mix new label 2024co2 o2 mix new label 2024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54776-004CARBON DIOXIDE OXYGEN MIXTURE GAS [SPEC CONNECTION INTERNATIONAL INC]8Legacy NDC20241121_6141646a-6440-c6e0-e053-2a91aa0aa236.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54776-00454776-004-01, 54776-004-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBON DIOXIDE142M471B3JIACT
OXYGENS88TT14065ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4265f983-a5d9-b31d-e063-6394a90a78096141646a-6440-c6e0-e053-2a91aa0aa2362025-10-30Exact identifier
spl set id: 6141646a-6440-c6e0-e053-2a91aa0aa236

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.