Label: OXYGEN gas
- NDC Code(s): 58089-001-01, 58089-001-02, 58089-001-03
- Packager: Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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.
Updated November 14, 2019
If you are a consumer or patient please visit this version.
Principal for Oxygen Product
CAS NO: 7782-44-7
REFRIGERATED LIQUEFIED OXIDIZING GAS. ALWAYS
KEEP CONTAINER IN UPRIGHT POSITION. DO NOT
CHANGE OR FORCE FIT CONNECTIONS. MAY CAUSE OR INTENSIFY
FIRE; OXIDIZER, CONTAINS REFRIGERATED GAS: MAY CAUSE
CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH
LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.
Do not get in eyes, on skin, or on clothing. Keep reduction valves free
from grease and oil. In case of fire, stop leak if safe to do so. Avoid
spills. Do not walk or roll equipment over spills. Store and use in a well
ventilated place. Use only with equipment of compatible materials
of construction and rated for cylinder pressure. Wear cold insulating
gloves/face shield/eye protection. Protect from sunlight when ambient
temperature exceeds 52 F. Container temperature should
not exceed 52 F. Close valve after each use and when
empty. Use a back flow preventative device in the piping. Do not
handle until all safety precautions have been read and understood.
Use only with equipment cleaned for oxygen service. Keep/store away
from combustible materials. Do not drop. Use suitable hand truck for
IN CASE OF FROSTBITE: Thaw frosted parts with lukewarm water.
Do not rub affected area. Get immediate medical advice/attention.
DO NOT REMOVE THIS PRODUCT LABEL.
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. Use only with pressure
reducing equipment and apparatus designed for oxygen. Do not
attempt to use on patients who have stopped breathing unless used in
conjunction with resuscitative equipment. Produced by Air Liquefaction.
ALWAYS KEEP CONTAINER IN UPRIGHT POSITION
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58089-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58089-001-02 45 L in 1 DEWAR; Type 0: Not a Combination Product 12/02/2009 2 NDC:58089-001-03 60 L in 1 DEWAR; Type 0: Not a Combination Product 12/02/2009 3 NDC:58089-001-01 41 L in 1 DEWAR; Type 0: Not a Combination Product 12/02/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 12/02/2009 Labeler - Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment (161365424) Establishment Name Address ID/FEI Business Operations Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment 081030274 manufacture(58089-001) Establishment Name Address ID/FEI Business Operations Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment 161365424 manufacture(58089-001)