OXYGEN- oxygen gas 
OXYGEN- oxygen liquid 
BayCare Home Care, 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.

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Oxygen

Oxygen U.S.P.


Oxygen Gas Label










UN1072
WARNING!
High Pressure Oxidizing Gas Vigorously Accelerates Combustion

Produced by Air Liquefaction

Warning!
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.

Caution: RX ONLY
For other medical applications, use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours, may be harmful. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.

Keep out of reach of children. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with pressure reducing equipment and apparatus designed for oxygen service and rated for cylinder pressure. Open valve slowly before use. Close valve after each use and when empty.

Federal law requires that this container be refilled with Gaseous Oxygen USP only by establishments registered as a Drug producer in accordance with the Federal Food, Drug and Cosmetic Act.

Refrigerated Liquid Oxygen U.S.P.

Oxygen Liquid Label











UN1073
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   

Caution:  RX Only
Warning!

Keep oil, grease and combustibles away. 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.

Keep out of reach of children. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with equipment and apparatus conditioned for oxygen service.

Use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.

Federal law requires that this container be refilled with Liquid Oxygen USP only by establishments registered as a Drug Producer in accordance with the Federal Food, Drug and Cosmetic Act.

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59400-001
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxygen (Oxygen) Oxygen210 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59400-001-01670 L in 1 CYLINDER
2NDC:59400-001-02425 L in 1 CYLINDER
3NDC:59400-001-03140 L in 1 CYLINDER
4NDC:59400-001-047760 L in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas10/29/2013
OXYGEN 
oxygen liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:59400-005
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxygen (Oxygen) Oxygen210 mg  in 1 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59400-005-0134168 kg in 1 DEWAR
2NDC:59400-005-0237585 kg in 1 DEWAR
3NDC:59400-005-0325626 kg in 1 DEWAR
4NDC:59400-005-0417084 kg in 1 DEWAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas11/05/2013
Labeler - BayCare Home Care, Inc. (794046607)
Registrant - BayCare Home Care, Inc. (794046607)
Establishment
NameAddressID/FEIBusiness Operations
BayCare Home Care, Inc.794046607manufacture(59400-001, 59400-005)
Establishment
NameAddressID/FEIBusiness Operations
BayCare Home Care, Inc.832097617manufacture(59400-001, 59400-005)
Establishment
NameAddressID/FEIBusiness Operations
BayCare Home Care, Inc.832097591manufacture(59400-001, 59400-005)

Revised: 10/2014
Document Id: a6781cb9-b36d-488c-9689-8bb6be9debd7
Set id: 5e7deef4-d5c7-4133-aa2b-e31eeb9a6d7c
Version: 18
Effective Time: 20141014
 
BayCare Home Care, Inc.