Label: AIR gas
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NDC Code(s):
46123-109-01,
46123-109-02,
46123-109-03,
46123-109-04, view more46123-109-05, 46123-109-06, 46123-109-07
- Packager: Roberts Oxygen Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 16, 2023
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PRINCIPAL DISPLAY PANEL
AIR, COMPRESSED USP
UN1002
WARNING: For breathing support when used by properly trained personnel. For medical applications, Rx only. Administration of Medical Air 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 Medical Air 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. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. SUPPORTS COMBUSTION. Do not handle until all safety precautions have been read and understood. Use a back flow preventive device in the piping. Use only equipment of compatible materials of construction and rated for cylinder pressure. 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: 132259-10-0 DO NOT REMOVE THIS PRODUCT LABEL.
Roberts Oxygen Company, Inc.
PO Box 5507 Rockville, MD 20855
301-948-8100
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INGREDIENTS AND APPEARANCE
AIR
air gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-109 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 210 mL in 1 L Inactive Ingredients Ingredient Name Strength NITROGEN (UNII: N762921K75) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46123-109-01 708 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 2 NDC:46123-109-02 2180 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 3 NDC:46123-109-03 2264 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 4 NDC:46123-109-04 3993 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 5 NDC:46123-109-05 4163 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 6 NDC:46123-109-06 7363 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 7 NDC:46123-109-07 8779 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 01/01/1967 Labeler - Roberts Oxygen Company, Inc. (042646877) Registrant - Roberts Oxygen Company, Inc. (042646877) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 020325953 manufacture(46123-109) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 791818008 manufacture(46123-109)