Oxygen

Oxygen

Drug Labeling and Warnings

Drug Details

k">

OXYGEN- oxygen gas 
Med-Caire Inc.

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.

----------

Oxygen

Principal for Oxygen Product

RepresentativeHPLabel

COMPRESSED

USP

UN 1072

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 when ambient temperature exceeds 52 °c (125 °F). Read and follow the Safety Data Sheet (SDS) before use.

CAS NO: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

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 effect on oxygen

content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction.

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 63173-001
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63173-001-01164 L in 1 CYLINDER; Type 0: Not a Combination Product01/30/2002
2NDC: 63173-001-053455 L in 1 CYLINDER; Type 0: Not a Combination Product01/30/2002
3NDC: 63173-001-02255 L in 1 CYLINDER; Type 0: Not a Combination Product01/30/2002
4NDC: 63173-001-03425 L in 1 CYLINDER; Type 0: Not a Combination Product01/30/2002
5NDC: 63173-001-04680 L in 1 CYLINDER; Type 0: Not a Combination Product01/30/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/30/2002
Labeler - Med-Caire Inc. (024555708)
Establishment
NameAddressID/FEIBusiness Operations
Med-Caire Inc.024555708manufacture(63173-001)
Establishment
NameAddressID/FEIBusiness Operations
Med-Caire Inc.041549266manufacture(63173-001)

Revised: 2/2019
 
Med-Caire Inc.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.