Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 45782-0000-1, 45782-0000-2, 45782-0000-3, 45782-0000-4, view more45782-0000-5 - Packager: Mountain Valley Home Medical Equipment, Inc
- 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
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- Official Label (Printer Friendly)
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OXYGEN COMPRESSED LABEL
OXYGEN COMPRESSED USP UN1072 OXYGEN-2 WARNING HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. PRODUCED BY AIR LIQUEFACTION. WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY. DO NOT USE HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAT 5 HOURS, MAY BE HARMFUL. DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT. KEEP CYLINDER, CYLINDER VALVE, ALL EQUIPMENT AND CONNECTIONS FREE OF OIL AND GREASE TO AVOID VIOLENT IGNITION. OPEN VALVE SLOWLY. DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME. USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED AND CLEANED FOR USE WITH OXYGEN. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. FEDERAL LAW REQUIRES THIS CONTAINER BE REFILLED WITH OXYGEN USP ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD DRUG AND COSMETIC ACT.
LOT NUMBER__________ EXPIRATION DATE________________ LITERS________________ A80024 ECN-13324 MADE IN USA
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45782-0000 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:45782-0000-1 113 L in 1 CYLINDER 2 NDC:45782-0000-2 168 L in 1 CYLINDER 3 NDC:45782-0000-3 253 L in 1 CYLINDER 4 NDC:45782-0000-4 422 L in 1 CYLINDER 5 NDC:45782-0000-5 681 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/2006 Labeler - Mountain Valley Home Medical Equipment, Inc (780346263) Registrant - Mountain Valley Home Medical Equipment, Inc (780346263) Establishment Name Address ID/FEI Business Operations Mountain Valley Home Medical Equipment, Inc 780346263 manufacture