OXYGEN GAS [J & M CYLINDER GASES, INC.]

OXYGEN GAS [J & M CYLINDER GASES, INC.]
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NDC 63862-001-01, 63862-001-02, 63862-001-03, 63862-001-04, 63862-001-05, 63862-001-06
Set ID 61d0cf43-faef-2c08-e053-2a91aa0a6d62
Category HUMAN PRESCRIPTION DRUG LABEL
Packager J & M CYLINDER GASES, INC.
Generic Name
Product Class
Product Number
Application Number NDA205865
  • 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. 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.

    J & M Cylinder Gases, Inc.

    Because Contents Count

    1702 FIFTH STREET NW

    DECATUR, AL 35601

    (256) 355-2426 oxygen

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63862-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99.5 L  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63862-001-01198.22 L in 1 CYLINDER; Type 0: Not a Combination Product11/07/1997
    2NDC:63862-001-02424.75 L in 1 CYLINDER; Type 0: Not a Combination Product11/07/1997
    3NDC:63862-001-03707.92 L in 1 CYLINDER; Type 0: Not a Combination Product11/07/1997
    4NDC:63862-001-047107.53 L in 1 CYLINDER; Type 0: Not a Combination Product11/07/1997
    5NDC:63862-001-05160 L in 1 DEWAR; Type 0: Not a Combination Product11/07/1997
    6NDC:63862-001-06180 L in 1 DEWAR; Type 0: Not a Combination Product11/07/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20586511/07/1997
    Labeler - J & M CYLINDER GASES, INC. (006977941)
    Establishment
    NameAddressID/FEIBusiness Operations
    J & M CYLINDER GASES, INC.006977941manufacture(63862-001)

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