Label: HELIUM gas
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Contains inactivated NDC Code(s)
NDC Code(s): 10006-008-01, 10006-008-02, 10006-008-03, 10006-008-04, view more10006-008-05, 10006-008-06 - Packager: Acetylene Oxygen Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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.
Drug Label Information
Updated April 27, 2011
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- Official Label (Printer Friendly)
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HELIUM HP USP SHOULDER LABEL
HELIUM COMPRESSED USP UN 1046 NON-FLAMMABLE 37580 (R 06/05)
Rx ONLY.
WARNING: ADMINISTRATION OF HELIUM 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 HELIUM AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN.
CAUTION; HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION. STORE AND USE WITH ADEQUATE VENTILATION. USE EQUIPMENT RATED FOR CYLINDER PRESSURE. USE A BACK FLOW PREVENTIVE VALVE AFTER EACH USE. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52C (125 F) CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)
INHALING HELIUM TO ALTER VOICE MAY PROVE TO BE FATAL AND SHOULD NOT BE PERMITTED.
FIRST AID: IF INHALED, REMOVE TO FRESH AIR. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. IF BREATHING IS DIFFICULT, GIVE OXYGEN. CALL A PHYSICIAN
CAS: 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL
CONTENTS______ LITERS _______CU.FT
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INGREDIENTS AND APPEARANCE
HELIUM
helium gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10006-008 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10006-008-01 283 L in 1 CYLINDER 2 NDC:10006-008-02 425 L in 1 CYLINDER 3 NDC:10006-008-03 566 L in 1 CYLINDER 4 NDC:10006-008-04 2266 L in 1 CYLINDER 5 NDC:10006-008-05 3455 L in 1 CYLINDER 6 NDC:10006-008-06 6032 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1936 Labeler - Acetylene Oxygen Company (008110181) Registrant - Acetylene Oxygen Company (008110181) Establishment Name Address ID/FEI Business Operations Acetylene Oxygen Company 809889033 manufacture