SPL v8
SPL
SPL Set ID 2264fffc-ddcb-4f5b-97ca-52b805a2dbd1
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2015-07-20
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (99.9 L)

Identifiers & Packaging

Marketing Status
UNAPPROVED MEDICAL GAS Active Since 1977-01-01

Description

KEEP OUT OF REACH OF CHILDREN.  CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION.  KEEP FREE FROM OIL AND GREASE.  DON NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE.  FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN U.S.P. ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS, Rx ONLY. UN INTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN. LOT# __________ WT. _____________ CONTENTS_________________

Warnings and Precautions

KEEP OUT OF REACH OF CHILDREN.  CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION.  KEEP FREE FROM OIL AND GREASE.  DON NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE.  FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN U.S.P. ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS, Rx ONLY. UN INTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN. LOT# __________ WT. _____________ CONTENTS_________________


Medication Information

Warnings and Precautions

KEEP OUT OF REACH OF CHILDREN.  CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION.  KEEP FREE FROM OIL AND GREASE.  DON NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE.  FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN U.S.P. ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS, Rx ONLY. UN INTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN. LOT# __________ WT. _____________ CONTENTS_________________

Description

KEEP OUT OF REACH OF CHILDREN.  CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION.  KEEP FREE FROM OIL AND GREASE.  DON NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE.  FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN U.S.P. ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS, Rx ONLY. UN INTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN. LOT# __________ WT. _____________ CONTENTS_________________

Oxygen Compressed Label

OXYGEN COMPRESSED U.S.P. UN 1072 OXYGEN-2

WARNING HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION PRODUCED BY AIR LIQUEFACTION

DO NOT REMOVE THIS PRODUCT LABEL

Product Warnings and Precautions

KEEP OUT OF REACH OF CHILDREN.  CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION.  KEEP FREE FROM OIL AND GREASE.  DON NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE. 

FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN U.S.P. ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS, Rx ONLY.

UN INTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.

LOT# __________ WT. _____________ CONTENTS_________________


Structured Label Content

Oxygen Compressed Label (OXYGEN COMPRESSED LABEL)

OXYGEN COMPRESSED U.S.P. UN 1072 OXYGEN-2

WARNING HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION PRODUCED BY AIR LIQUEFACTION

DO NOT REMOVE THIS PRODUCT LABEL

Product Warnings and Precautions (PRODUCT WARNINGS AND PRECAUTIONS)

KEEP OUT OF REACH OF CHILDREN.  CONTENTS UNDER PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION.  KEEP FREE FROM OIL AND GREASE.  DON NOT USE OR STORE NEAR HEAT OR OPEN FLAME AND USE ONLY WITH EQUIPMENT CONDITIONED FOR OXYGEN SERVICE. 

FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN U.S.P. ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS, Rx ONLY.

UN INTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.

LOT# __________ WT. _____________ CONTENTS_________________


Advanced Ingredient Data


Raw Label Data

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