Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 62000-321-01, 62000-321-02, 62000-321-03, 62000-321-04, view more62000-321-05, 62000-321-06, 62000-321-07, 62000-321-08, 62000-321-09, 62000-321-10, 62000-321-11, 62000-321-12, 62000-321-13 - Packager: Medical Home Care, 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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OXYGEN COMPRESSED LABEL
OXYGEN COMPRESSED U.S.P. UN 1072 WARNING! HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION - OXYGEN - 2 - PRODUCED BY AIR LIQUEFACTION. UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS, MAY BE HARMFUL. USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN. CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION. KEEP OIL AND GREASE AWAY. OPEN VALVE SLOWLY. USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.
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OXYGEN REFRIGERATED LIQUID LABEL
OXYGEN REFRIGERATED LIQUID U.S.P. UN 1073 WARNING! HIGH PRESSURE OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE. PRODUCED BY AIR LIQUEFACTION. OXYGEN - 2
WARNING! ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. Rx ONLY
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. IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY. CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION. KEEP FREE OF OIL AND GREASE. DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE.
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GENERAL WARNINGS AND PRECAUTIONS
FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY. FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN U.S.P. ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG AND COSMETIC ACT.
DO NOT REMOVE THIS LABEL
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62000-321 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99.6 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62000-321-01 164 L in 1 CYLINDER 2 NDC:62000-321-02 248 L in 1 CYLINDER 3 NDC:62000-321-03 414 L in 1 CYLINDER 4 NDC:62000-321-04 682 L in 1 CYLINDER 5 NDC:62000-321-05 3452 L in 1 CYLINDER 6 NDC:62000-321-06 21 L in 1 CYLINDER 7 NDC:62000-321-07 31 L in 1 CYLINDER 8 NDC:62000-321-08 41 L in 1 CYLINDER 9 NDC:62000-321-09 180 L in 1 CYLINDER 10 NDC:62000-321-10 36 L in 1 CYLINDER 11 NDC:62000-321-11 41 L in 1 DEWAR 12 NDC:62000-321-12 46 L in 1 CYLINDER 13 NDC:62000-321-13 180 L in 1 DEWAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1992 Labeler - Medical Home Care, Inc (606641827) Registrant - Medical Home Care, Inc (606641827) Establishment Name Address ID/FEI Business Operations Medical Home Care, Inc 606641827 manufacture