Label: OXYGEN gas
11928-002-04, view more11928-002-05
- Packager: Mada Medical Products, Inc.
- This is a repackaged label.
- Source NDC Code(s): 25543-200
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated February 3, 2022
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PRINCIPAL DISPLAY PANEL
USP 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 effects on oxygen content of arterial blood, may be hamful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE, MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight whem ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.
DO NOT REMOVE THIS PRODUCT LABEL
170 Liters M6
200 Liters M7
255 Liters M9
425 Liters MD
680 Liters ME
___ Liters Other
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11928-002(NDC:25543-200) Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 1 L in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11928-002-02 200 L in 1 CANISTER; Type 0: Not a Combination Product 06/16/2004 2 NDC:11928-002-03 255 L in 1 CANISTER; Type 0: Not a Combination Product 06/16/2004 3 NDC:11928-002-04 425 L in 1 CANISTER; Type 0: Not a Combination Product 06/16/2004 4 NDC:11928-002-05 680 L in 1 CANISTER; Type 0: Not a Combination Product 06/16/2004 5 NDC:11928-002-01 170 L in 1 CANISTER; Type 0: Not a Combination Product 06/16/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205840 06/16/2004 Labeler - Mada Medical Products, Inc. (048411862) Registrant - Mada Medical Products, Inc. (048411862) Establishment Name Address ID/FEI Business Operations Mada Medical Products, Inc. 048411862 repack(11928-002) Establishment Name Address ID/FEI Business Operations Airgas USA, LLC 788120074 manufacture(11928-002)