Label: HYPERBARIC CHAMBER MIX gas
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Contains inactivated NDC Code(s)
NDC Code(s): 54776-002-01 - Packager: Spec Connection International Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 27, 2012
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PRINCIPAL DISPLAY PANEL
OXYGEN 2 NON-FLAMMABLE GAS 2 Compressed gas, oxidizing, n.o.s. (Oxygen, Nitrogen) UN3156 Medical Gas Mixture 50% Oxygen, USP CAS: 7782-44-7 Balance Nitrogen, NF CAS: 7727-37-9 CAUTION: Federal law prohibits dispensing without a prescription. Rx only. WARNING: OXIDIZIN HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. 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. 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. Use in accordance with the appropriate MSDS for each mixture component. Secure cylinder while in transportation, storage and in use. Serial Number: 49284750 In Emergency Call: 1-800-494-9300 Lot No.: 338sci12dp1 - Volume: 200 - Exp. Date: 12/11/17 Label #: HC101 December 12, 2012 Ver. 2.33 For Medical Use Only. Spec Connection International Inc 37325 sr 54 Zephyrhills FL 33542 Ph# 813-997-8950 DO NOT REMOVE THIS PRODUCT LABEL
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INGREDIENTS AND APPEARANCE
HYPERBARIC CHAMBER MIX
hyperbaric chamber mix gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54776-002 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 500 mL in 1 L Nitrogen (UNII: N762921K75) (Nitrogen - UNII:N762921K75) Nitrogen 500 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54776-002-01 5663 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/2013 Labeler - Spec Connection International Inc (059854468) Establishment Name Address ID/FEI Business Operations Spec Connection International, Inc. 026151816 manufacture(54776-002)