OXYGEN - oxygen gas 
Purepoint, 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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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.

HP LABEL

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


LIQUID LABEL

COA TAG

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46088-010
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46088-010-01113 L in 1 CYLINDER
2NDC:46088-010-02170 L in 1 CYLINDER
3NDC:46088-010-03139 L in 1 CYLINDER
4NDC:46088-010-04248 L in 1 CYLINDER
5NDC:46088-010-05647 L in 1 CYLINDER
6NDC:46088-010-061724 L in 1 CYLINDER
7NDC:46088-010-07255 L in 1 CYLINDER
8NDC:46088-010-08426 L in 1 CYLINDER
9NDC:46088-010-09671 L in 1 CYLINDER
10NDC:46088-010-103462 L in 1 CYLINDER
11NDC:46088-010-117981 L in 1 CYLINDER
12NDC:46088-010-1221 L in 1 DEWAR
13NDC:46088-010-1331 L in 1 DEWAR
14NDC:46088-010-1436 L in 1 DEWAR
15NDC:46088-010-1541 L in 1 DEWAR
16NDC:46088-010-1645 L in 1 DEWAR
17NDC:46088-010-17180 L in 1 DEWAR
18NDC:46088-010-18181 L in 1 DEWAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/2008
Labeler - Purepoint, Inc (831833707)
Registrant - Purepoint, Inc (831833707)
Establishment
NameAddressID/FEIBusiness Operations
Purepoint, Inc831833707manufacture

Revised: 8/2011
Document Id: f74dc486-5967-427c-aa71-166f11574950
Set id: edb4a431-46eb-4ba2-bd4e-356c60c48773
Version: 2
Effective Time: 20110824
 
Purepoint, Inc