NITROUS OXIDE- nitrous oxide gas 
Air Liquide Healthcare America Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Nitrous Oxide Label

WARNING: DO NOT HANDLE CYLINDER OR USE CONTENTS UNTIL: 1) YOU HAVE READ AND UNDERSTAND THE MATERIAL SAFETY DATA SHEET FOR THIS PRODUCT.  CALL 1-800-231-1366 FOR MORE COPIES. 2) YOU ARE TRAINED TO USE CYLINDER AND CONTENTS, INCLUDING EMERGENCY PROCEDURES.

WARNING: ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  CAN CAUSE RAPID SUFFOCATION AND DEATH WITHOUT WARNING (DUE TO OXYGEN DEFICIENCY).  CAN CAUSE ANESTHETIC EFFECTS.  MAY CAUSE FROSTBITE.  MAY CAUSE NERVOUS SYSTEM INJURY AND EMBRYO FETAL TOXICITY.  Avoid breathing gas. Store and use with adequate ventilation.  Keep oil, grease, and combustibles away.  No smoking in container area.  Do not use or store near heat or open flame.  Use only with equipment cleaned for oxygen service.  Do not get liquid in eyes, on skin or clothing.  For liquid withdrawal, wear face shield and gloves.  Do not drop or handle container roughly.  Use suitable hand truck for container movement.  Avoid spills.  Do not walk on or roll equipment over spills.  Use a back-flow preventive device in the piping.  Container temperature should not exceed 125°F (52°C).  Close valve after each use and when empty.  Use in accordance with Material Safety Data Sheet.

FIRST AID:  IF INHALED, remove to fresh air.  If not breathing, give artificial respiration. If breathing is difficult, give oxygen.  Call a physician.  IN CASE OF FROSTBITE, obtain medical treatment immediately.  

WARNING:  Administration of Nitrous Oxide 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 Nitrous Oxide, 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.

CAUTION: Federal law prohibits dispensing without prescription.  

CAUTION: USE NO OIL ON VALVE OR CONNECTIONS.  TRANSFILLING OF THIS LIQUID OR GAS IS PROHIBITED.

DO NOT REMOVE THIS PRODUCT LABEL.

Label

NITROUS OXIDE 
nitrous oxide gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64735-041
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64735-041-42160 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/196010/01/2016
2NDC:64735-041-43180 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/196010/01/2016
3NDC:64735-041-44230 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/196010/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/196010/01/2016
Labeler - Air Liquide Healthcare America Corporation (087757167)
Registrant - Air Liquide Healthcare America Corporation (087757167)
Establishment
NameAddressID/FEIBusiness Operations
Air Liquide Healthcare America Corporation808357268manufacture(64735-041)

Revised: 10/2016
 
Air Liquide Healthcare America Corporation