NDC Code(s) : 68693-003-01, 68693-003-02, 68693-003-03, 68693-003-04, 68693-003-05, 68693-004-01, 68693-004-02, 68693-004-03, 68693-004-04, 68693-004-05, 68693-006-01, 68693-006-02, 68693-006-03, 68693-006-04, 68693-006-05, 68693-005-01, 68693-005-02, 68693-005-03, 68693-005-04, 68693-005-05
Packager : Specialty Gases of America

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

COMPRESSEDCARBON DIOXIDE OXYGEN MIXTURE GAS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68693-003
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYGEN(UNII: S88TT14065)
(OXYGEN - UNII:S88TT14065) 		OXYGEN80 L in 100 L
Inactive Ingredients
Ingredient Name Strength
CARBON DIOXIDE(UNII: 142M471B3J)20 L in 100 L
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68693-003-01426 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
2NDC:68693-003-02671 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
3NDC:68693-003-033462 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
4NDC:68693-003-046482 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
5NDC:68693-003-057415 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/1995 06/10/2015
COMPRESSEDCARBON DIOXIDE OXYGEN MIXTURE GAS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68693-004
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYGEN(UNII: S88TT14065)
(OXYGEN - UNII:S88TT14065) 		OXYGEN90 L in 100 L
Inactive Ingredients
Ingredient Name Strength
CARBON DIOXIDE(UNII: 142M471B3J)10 L in 100 L
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68693-004-01426 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
2NDC:68693-004-02671 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
3NDC:68693-004-033462 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
4NDC:68693-004-046482 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
5NDC:68693-004-057415 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/1995 06/10/2015
COMPRESSEDCARBON DIOXIDE OXYGEN MIXTURE GAS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68693-006
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYGEN(UNII: S88TT14065)
(OXYGEN - UNII:S88TT14065) 		OXYGEN95 L in 100 L
Inactive Ingredients
Ingredient Name Strength
CARBON DIOXIDE(UNII: 142M471B3J)5 L in 100 L
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68693-006-01426 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
2NDC:68693-006-02671 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
3NDC:68693-006-033462 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
4NDC:68693-006-046482 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
5NDC:68693-006-057415 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/1995 06/10/2015
COMPRESSEDCARBON DIOXIDE OXYGEN MIXTURE GAS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68693-005
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYGEN(UNII: S88TT14065)
(OXYGEN - UNII:S88TT14065) 		OXYGEN96 L in 100 L
Inactive Ingredients
Ingredient Name Strength
CARBON DIOXIDE(UNII: 142M471B3J)4 L in 100 L
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68693-005-01426 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
2NDC:68693-005-02671 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
3NDC:68693-005-033462 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
4NDC:68693-005-046482 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
5NDC:68693-005-057415 L in 1 CYLINDER Type 0: Not a Combination Product01/01/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/1995 06/10/2015

PRINCIPAL DISPLAY PANEL

COMPRESSED GAS OXIDIZING, N.O.S.  NON-FLAMMABLE GAS - 2 OXIDIZER - 5.1 (___% CARBON DIOXIDE USP, _% OXYGEN USP) UN3156 Rx ONLY.  CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.  WARNING: ADMINISTRATION OF THIS GAS MAY BE HAZARDOUS OR CONTRAINDICATED.  FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF GAS MIXTURES AND IS FAMILIAR WITH THE INDICATIONS, AFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS, AND SIDE EFFECTS AND PRECAUTIONS TO BE TAKEN

CAS: CARBON DIOXIDE 124-38-9   OXYGEN 7782-44-7  DO NOT REMOVE THIS PRODUCT LABEL.  IN CASE OF EMERGENCY CALL CHEMTREC: 800-424-9300 ACCUMED tm

PERCENTAGES LISTED ARE NOMINAL, REFER TO CERTIFICATE OF ANALYSIS RESULT

WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION, MIXTURES CONTAINING CARBON DIOXIDE CAN INCREASE RESPIRATION AND HEART RATE. KEEP OIL AND GREASE AWAY. OPEN VALVE SLOWLY. STORE AND USE WITH ADEQUATE VENTILATION. USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F). CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. FIRST AID: IF INHALED, REMOVE TO FRESH AIR. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. IF BREATHING IS DIFFICULT, GIVE OXYGEN. CALL A PHYSICIAN.

AGG-36 (R 06/08)

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