Oxygen Refrigerated Liquid, Usp-045

Oxygen Refrigerated Liquid, Usp-045
SPL v9
SPL
SPL Set ID c2b0f2bd-2ce2-4096-8aae-07d2200a015b
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2016-12-13
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (990 mL)

Identifiers & Packaging

Marketing Status
NDA Active Since 2014-01-01

Description

ROBERTS OXYGEN ROCKVILLE, MARYLAND 20866 TEL: (301) 948-8100 CERTIFICATE OF ANALYSIS OXYGEN REFRIGERATED LIQUID, USP* PRODUCED BY AIR-LIQUEFACTION PROCESS TRAILER#: ______________ DATE:  _________________ LOT#: _________________ *USP applies only when used in a medical application or by medical customers properly registered with the FDA. Component Test Method Limit Result Oxygen ______ >99.5% _______ Odor ORGANOLEPTIC N/D ______ ________ _________ _________ _________ Product is identified as OXYGEN, USP through process validations, dedicated piping, and product specific connections. Notes:  _____________________________________ RELEASED BY: ____________________________ SIGNATURE RELEASED BY: ____________________________ PRINTED NAME Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP (800) 327-6868 *jjkeller.com * Printer in the Unitied States


Medication Information

Description

ROBERTS OXYGEN ROCKVILLE, MARYLAND 20866 TEL: (301) 948-8100 CERTIFICATE OF ANALYSIS OXYGEN REFRIGERATED LIQUID, USP* PRODUCED BY AIR-LIQUEFACTION PROCESS TRAILER#: ______________ DATE:  _________________ LOT#: _________________ *USP applies only when used in a medical application or by medical customers properly registered with the FDA. Component Test Method Limit Result Oxygen ______ >99.5% _______ Odor ORGANOLEPTIC N/D ______ ________ _________ _________ _________ Product is identified as OXYGEN, USP through process validations, dedicated piping, and product specific connections. Notes:  _____________________________________ RELEASED BY: ____________________________ SIGNATURE RELEASED BY: ____________________________ PRINTED NAME Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP (800) 327-6868 *jjkeller.com * Printer in the Unitied States

Section 51945-4

ROBERTS OXYGEN

ROCKVILLE, MARYLAND 20866

TEL: (301) 948-8100

CERTIFICATE OF ANALYSIS

OXYGEN REFRIGERATED LIQUID, USP*

PRODUCED BY AIR-LIQUEFACTION PROCESS

TRAILER#: ______________

DATE:  _________________

LOT#: _________________

*USP applies only when used in a medical application or by medical customers properly registered with the FDA.

Component Test Method Limit Result

Oxygen ______ >99.5% _______

Odor ORGANOLEPTIC N/D ______

________ _________ _________ _________

Product is identified as OXYGEN, USP through process validations, dedicated piping, and product specific connections.

Notes:  _____________________________________

RELEASED BY: ____________________________

SIGNATURE

RELEASED BY: ____________________________

PRINTED NAME



Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP

(800) 327-6868 *jjkeller.com * Printer in the Unitied States




Structured Label Content

Section 51945-4 (51945-4)

ROBERTS OXYGEN

ROCKVILLE, MARYLAND 20866

TEL: (301) 948-8100

CERTIFICATE OF ANALYSIS

OXYGEN REFRIGERATED LIQUID, USP*

PRODUCED BY AIR-LIQUEFACTION PROCESS

TRAILER#: ______________

DATE:  _________________

LOT#: _________________

*USP applies only when used in a medical application or by medical customers properly registered with the FDA.

Component Test Method Limit Result

Oxygen ______ >99.5% _______

Odor ORGANOLEPTIC N/D ______

________ _________ _________ _________

Product is identified as OXYGEN, USP through process validations, dedicated piping, and product specific connections.

Notes:  _____________________________________

RELEASED BY: ____________________________

SIGNATURE

RELEASED BY: ____________________________

PRINTED NAME



Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP

(800) 327-6868 *jjkeller.com * Printer in the Unitied States




Advanced Ingredient Data


Raw Label Data

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