Oxygen by Mada Medical Products, Inc. / Airgas USA, LLC OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Mada Medical Products, Inc., Airgas USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

OXYGEN,

COMPRESSED

USP

UN1072

OXYGEN

2

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.

CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL

Contents Size

170 Liters M6

200 Liters M7

255 Liters M9

425 Liters MD

680 Liters ME

___ Liters Other

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

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)