OXYGEN GAS [REGIONAL HOME CARE, INC.]

OXYGEN GAS [REGIONAL HOME CARE, INC.]
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NDC 53622-001-01, 53622-001-02, 53622-001-03, 53622-001-04, 53622-001-05
Set ID 7e5fe6ed-ddfa-4735-a65a-2d26cdc532ba
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Regional Home Care, Inc.
Generic Name
Product Class
Product Number
Application Number NDA205865
  • OXYGEN REFRIGERATED LIQUID USP LABEL

    OXYGEN REFRIGERATED LIQUID USP UN1073 

    CONTENTS_________ LITERS 

    CAS NO: 7782-44-7

    DANGER:
    MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED 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.

    DO NOT REMOVE THIS PRODUCT LABEL

    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 in arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Producted by Air Liquefaction.

    ©Applied Hone Health Equipment 2014

    Regional Home Care

    125 Tolman Avenue

    Leominster, MA 01453

    (978)840-0113

    RegionHC O2 Refrig Label

    res

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53622-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53622-001-0121 L in 1 DEWAR; Type 0: Not a Combination Product01/01/198201/01/2019
    2NDC:53622-001-0231 L in 1 DEWAR; Type 0: Not a Combination Product01/01/198201/01/2019
    3NDC:53622-001-0336 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1982
    4NDC:53622-001-0441 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1982
    5NDC:53622-001-0546 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1982
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20586501/01/1982
    Labeler - Regional Home Care, Inc. (131670796)
    Registrant - Regional Home Care, Inc. (131670796)
    Establishment
    NameAddressID/FEIBusiness Operations
    Regional Home Care, Inc.131670796manufacture(53622-001)

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