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OXYGEN

Purepoint, Inc
Purepoint, Inc


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OXYGEN COMPRESSED USP LABEL

OXYGEN COMPRESSED USP UN1072  C.A.S. NO. 7782-44-7  OXYGEN-2  WARNING: HIGH PRESSURE OXIDIZING GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  STORE AND USE WITH ADEQUATE VENTILATION.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F)  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)  DO NOT REMOVE THIS PRODUCT LABEL.

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  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.  PRODUCED BY AIR LIQUEFACTION.

OXYGEN

OXYGEN REFRIGERATED LIQUID USP LABEL

OXYGEN REFRIGERATED LIQUID USP UN1073   ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.    EXTREMELY COLD LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.  KEEP OIL, GREASE AND COMBUSTIBLES AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE.  STORE AND USE WITH ADEQUATE VENTILATION.  DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES.  DO NOT DROP.  USE HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK OR ROLL EQUIPMENT OVER SPILLS   CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.   

FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.
KEEP OUT OF THE REACH OF CHILDREN.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME.  FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH LIQUID OXYGEN USP ONLY BE ESTABLISHED REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD DRUG AND COSMETIC ACT.  PRODUCED BY AIR LIQUEFACTION.  DO NOT REMOVE THIS PRODUCT LABEL.

LOT NUMBER_____________ SERIAL NUMBER__________ AMOUNT__________INS, LBS., GALS., LITERS, CU. FT.

USP TESTS

TEST      ID      ODOR      ASSAY

LIMITS   OK      NONE      LESS THAN 99.2%

RESULT

FOR CUSTOMER TO USE TO DOCUMENT TESTS PERFORMED ON THIS VESSEL

METHOD OF ANALYSIS FOR ASSAY IS THE PARAMAGNETIC OXYGEN ANALYZER  MANUFACTURER__________ MODEL______________ CUSTOMER WITNESSED TESTS  YES   NO    SUPPLIERS SIGNATURE__________ DATE____________  CUSTOMERS SIGNATURE_______________ DATE________________

LIQUID MEDICAL GASES  LIQUID OXYGEN DELIVERY TAG  FILLED AND DISTRIBUTED BY____________ THIS VESSEL CONTAINS OXYGEN USP (SEE REVERSE SIDE FOR TEST RESULTS) OXYGEN PRODUCED BY THE AIR LIQUEFACTION PROCESS


OXYGEN

OXYGEN

OXYGEN

OXYGEN GAS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:46088-010
Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oxygen Oxygen 99 L

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46088-010-01 113 in 1 CYLINDER
2 NDC:46088-010-02 170 in 1 CYLINDER
3 NDC:46088-010-03 139 in 1 CYLINDER
4 NDC:46088-010-04 248 in 1 CYLINDER
5 NDC:46088-010-05 647 in 1 CYLINDER
6 NDC:46088-010-06 1724 in 1 CYLINDER
7 NDC:46088-010-07 255 in 1 CYLINDER
8 NDC:46088-010-08 426 in 1 CYLINDER
9 NDC:46088-010-09 671 in 1 CYLINDER
10 NDC:46088-010-10 3462 in 1 CYLINDER
11 NDC:46088-010-11 7981 in 1 CYLINDER
12 NDC:46088-010-12 21 in 1 DEWAR
13 NDC:46088-010-13 31 in 1 DEWAR
14 NDC:46088-010-14 36 in 1 DEWAR
15 NDC:46088-010-15 41 in 1 DEWAR
16 NDC:46088-010-16 45 in 1 DEWAR
17 NDC:46088-010-17 180 in 1 DEWAR
18 NDC:46088-010-18 181 in 1 DEWAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2008-01-01


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