NITROUS OXIDE - nitrous oxide gas 
Specialty Gases of America

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

NITROUS OXIDE USP UN 1070 NON-FLAMMABLE GAS - 2 OXIDIZER - 5.1 

Rx ONLY.  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

CAS 10024-97-2 AGG 16 (05/08)

NITROUS LABEL

GENERAL WARNINGS AND PRECAUTIONS

WARNING: HIGH PRESSURE OXIDIZING LIQUID AND GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  CAN CAUSE RAPID SUFFOCATION.  CAN CAUSE ANESTHETIC EFFECTS.  MAY CAUSE FROSTBITE.  AVOID BREATHING GAS.  STORE AND USE WITH ADEQUATE VENTILATION.  KEEP OIL AND GREASE AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN AND RATED FOR CYLINDER PRESSURE.  DO NOT GET LIQUID IN EYES ON SKIN OR CLOTHING.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  OPEN VALVE SLOWLY.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE A BACKFLOW PREVENTATIVE DEVICE IN THE PIPING.  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS).  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.  DO NOT REMOVE THIS PRODUCT LABEL.

NITROUS OXIDE 
nitrous oxide gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68693-010
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE99 kg  in 100 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68693-010-01.45 kg in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:68693-010-021.36 kg in 1 CYLINDER; Type 0: Not a Combination Product
3NDC:68693-010-032.27 kg in 1 CYLINDER; Type 0: Not a Combination Product
4NDC:68693-010-049.1 kg in 1 CYLINDER; Type 0: Not a Combination Product
5NDC:68693-010-0513.61 kg in 1 CYLINDER; Type 0: Not a Combination Product
6NDC:68693-010-0627.22 kg in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/199506/10/2015
Labeler - Specialty Gases of America (073446739)
Registrant - Specialty Gases of America (073446739)
Establishment
NameAddressID/FEIBusiness Operations
Specialty Gases of America036719938manufacture(68693-010)

Revised: 7/2015
 
Specialty Gases of America