Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 53828-001-01, 53828-001-02, 53828-001-03, 53828-001-04, view more53828-001-05, 53828-001-06, 53828-001-07, 53828-001-08, 53828-001-09, 53828-001-10, 53828-001-11, 53828-001-12, 53828-001-13, 53828-001-14 - Packager: Rochester Welding Supply Corp.
- 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 January 1, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OXYGEN COMPRESSED LABEL
- OXYGEN COMPRESSED LABEL
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REFRIGERATED LIQUID LABEL
OXYGEN REFRIGERATED LIQUID U.S.P. UN 1073 OXYGEN-2
GROSS WT:____ LBS. OZ. NET WT. _____________ LBS. OZ. SIZE______________ CONTENTS___________ LITERS
OXYGEN PRODUCED BY AIR LIQUEFACTION ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. DO NOT CHANGE OR FORCE FIT CONNECTIONS. EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE.
FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES. DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING. DO NOT DROP. USE HAND TRUCK SPECIFICALLY DESIGNED FOR LIQUID CYLINDER MOVEMENT. AVOID SPILLS. DO NOT WALK OR ROLL EQUIPMENT OVER SPILLS. USE IN ACCORDANCE WITH RWS MSDS-G046
IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY. CAS 7782-44-7 RWSLB5 REV 01/09 OXYGEN PRODUCED BY AIR LIQUEFACTION
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OXYGEN CERTIFICATE OF ANALYSIS
LOT NUMBER____ SERIAL NUMBER________ AMOUNT_____________ INS. LBS GALS LITERS CU FT
USP TESTS
TEST ID ODOR ASSAY
LIMITS OK NONE GREATER THAN OR EQUAL TO 99.2%
RESULTS __ _____ _______
FOR CUSTOMER USE TO DOCUMENT TESTS PERFORMED ON THIS VESSEL
METHOD OF ANALYSIS IS THE PARAMAGNETIC OXYGEN ANALYZER
MANUFACTURER __________ MODEL ________ CUSTOMER WITNESSED TESTS YES__ MO___ SUPPLIERS SIGNATURE _____________ DATE____ CUSTOMER'S SIGNATURE___________ DATE___________
LIQUID OXYGEN DELIVERY TAG THIS VESSEL CONTAINS OXYGEN U.S.P. (SEE REVERSE SIDE FOR TEST RESULTS) OXYGEN PRODUCED BY THE AIR LIQUEFACTION PROCESS - MEDICAL GASES
MANUFACTURED BY ROCHESTER WELDING SUPPLY CORP 510 STATE STREET ROCHESTER, NY 14608 585-325-4730
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PRODUCT WARNINGS AND PRECAUTIONS
KEEP ALL OIL, GREASE, AND HYDROCARBONS AWAY. USE ONLY WITH EQUIPMENT DESIGNED AND CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. OPEN VALVE SLOWLY AND CLOSE AFTER EACH USE. ALWAYS SECURE CYLINDER. STORE AND USE WITH ADEQUATE VENTILATION. USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 DEGREES C (125 DEGREES F) USE IN ACCORDANCE WITH RWS MSDS-OXY.
WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.
WARNING: UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION, WITHOUT MONITORING ITS EFFECT ON OXYGEN CONTENT OF ARTERIAL BLOOD, MAY BE HARMFUL. USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN. DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.
DO NOT REMOVE THIS PRODUCT LABEL.
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53828-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53828-001-01 90 L in 1 CYLINDER 2 NDC:53828-001-02 141 L in 1 CYLINDER 3 NDC:53828-001-03 234 L in 1 CYLINDER 4 NDC:53828-001-04 387 L in 1 CYLINDER 5 NDC:53828-001-05 643 L in 1 CYLINDER 6 NDC:53828-001-06 3172 L in 1 CYLINDER 7 NDC:53828-001-07 6400 L in 1 CYLINDER 8 NDC:53828-001-08 155223 L in 1 DEWAR 9 NDC:53828-001-09 8522 L in 1 CYLINDER 10 NDC:53828-001-10 1557 L in 1 CYLINDER 11 NDC:53828-001-11 153864 L in 1 DEWAR 12 NDC:53828-001-12 338870 L in 1 TANK 13 NDC:53828-001-13 387762 L in 1 TANK 14 NDC:53828-001-14 61911 L in 1 TANK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1935 Labeler - Rochester Welding Supply Corp. (013133509) Registrant - Rochester Welding Supply Corp. (013133509) Establishment Name Address ID/FEI Business Operations Rochester Welding Supply Corp. 013133509 manufacture