Country: United States
Language: English
Source: NLM (National Library of Medicine)
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)
Roberts Oxygen Company, Inc.
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
unapproved medical gas
OXYGEN-HELIUM MIXTURE - OXYGEN-HELIUM MIXTURE GAS ROBERTS OXYGEN COMPANY, 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._ ---------- OXYGEN - HELIUM MIXTURE UN1980 RARE GASES AND OXYGEN MIXTURES OXYGEN USP ________% CAS# 7782-44-7 HELIUM USP ________% CAS# 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL NON-FLAMMABLE GAS 2 ROBERTS OXYGEN COMPANY, INC. ROCKVILLE, MD 20855 PHONE: 301-948-8100 Rx ONLY. WARNING: ADMINISTRATION OF THIS MIXTURE 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 THIS MIXTURE AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS CONTRAINDICATED WITH THE SIDE EFFECTS, AND THE PRECAUTIONS TO BE TAKEN. WARNING: MIXTURES WITH CONCENTRATIONS OF OXYGEN IN EXCESS OF 23.5% MAY VIGOROUSLY ACCELERATE COMBUSTION. KEEP OIL AND GREASE AWAY. USE EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. OPEN VALVE SLOWLY. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. USE IN ACCORDANCE WITH MSDS AND CGA PAMPHLET P-1 AND P-2. Roberts Oxygen Company, Inc. OXYGEN-HELIUM MIXTURE oxygen-helium mixture gas PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:46 123-0 14 ROUTE OF ADMINISTRATION RESPIRATORY (INHALATION) ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O XYG EN (UNII: S8 8 TT140 6 5) (Oxygen - UNII:S8 8 TT140 6 5) Oxyge n 40 0 mL in 1 L INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH HELIUM (UNII: 20 6 GF3GB41) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:46 123-0 14-0 1 58 8 5 L in 1 CYLINDER MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE unappro ved medical gas 0 1/0 1/19 9 6 LABELER - Robe Read the complete document