Label: OXYGEN- oxygen gas
- NDC Code(s): 52481-2481-1, 52481-2481-2, 52481-2481-3, 52481-2481-4
- Packager: Genesis Respiratory Services
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 28, 2023
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- Official Label (Printer Friendly)
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PRODUCT WARNINGS AND PRECAUTIONS
KEEP OUT OF REACH OF CHILDREN. CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION. KEEP FREE FROM OIL AND GREASE. DON NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE.
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.
WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS, Rx ONLY.
UN INTERRUPTED 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.
LOT# __________ WT. _____________ CONTENTS_________________
- OXYGEN COMPRESSED LABEL
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52481-2481 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99.9 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52481-2481-1 164 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977 2 NDC:52481-2481-2 248 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977 3 NDC:52481-2481-3 415 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977 4 NDC:52481-2481-4 684 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1977 Labeler - Genesis Respiratory Services (097549687) Registrant - Genesis Respiratory Services (097549687) Establishment Name Address ID/FEI Business Operations Genesis Respiratory Services 097549687 manufacture(52481-2481) Establishment Name Address ID/FEI Business Operations Genesis Respiratory Services 059107649 manufacture(52481-2481) Establishment Name Address ID/FEI Business Operations Genesis Respiratory Services 803267280 manufacture(52481-2481) Establishment Name Address ID/FEI Business Operations Genesis Respiratory Services, Inc. 045717548 manufacture(52481-2481) Establishment Name Address ID/FEI Business Operations Genesis Respiratory Services 961780132 manufacture(52481-2481)
