NITROUS OXIDE - nitrous oxide gas 
Holston Gases, Inc

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 COMPRESSED LABEL

NITROUS OXIDE, COMPRESSED - NON-FLAMMABLE GAS - 2 - OXIDIZER USP UN 1070

WARNING SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE.

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION

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.

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 NITROUS OXIDE AND RATED FOR CYLINDER PRESSURE.  DO NOT GET LIQUID IN EYES ON SKIN OR CLOTHING.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 125 F (52 C)  OPEN VALVE SLOWLY  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)  NOTE: SUCK-BACK INTO CYLINDER MAY CAUSE RUPTURE.  ALWAYS USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  FIRST AID: IF INHALED REMOVE TO FRESH AIR.  IF NOT BREATHING GIVE ARTIFICIAL RESPIRATION.  IF BREATHING 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:55050-0008
Route of AdministrationRESPIRATORY (INHALATION)
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:55050-0008-12.90 kg in 1 CYLINDER
2NDC:55050-0008-29.07 kg in 1 CYLINDER
3NDC:55050-0008-325.4 kg in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1958
Labeler - Holston Gases, Inc (034697276)
Registrant - Holston Gases, Inc (034697276)
Establishment
NameAddressID/FEIBusiness Operations
Holston Gases, Inc034697276manufacture
Establishment
NameAddressID/FEIBusiness Operations
Holston Gases, Inc829338115manufacture

Revised: 1/2010
Document Id: 8f26ed93-327d-468a-ac00-c11e6aab2027
Set id: 213779ba-ba2f-4d5f-83bf-d57951d6bdb4
Version: 1
Effective Time: 20100101
 
Holston Gases, Inc