TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838), SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR), POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR, POT
Available from:
Baxter Healthcare Corporation
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 800 mg in 100 mL
Administration route:
IRRIGATION
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Isotonic solution for irrigation only. Not for injection.
Product summary:
Recommended storage: Room temperature (25°C). Avoid excessive heat.
Authorization status:
New Drug Application
Authorization number:
0338-0190-04

TIS-U-SOL- sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and

potassium phosphate irrigant

Baxter Healthcare Corporation

----------

DESCRIPTION

Tis-U-Sol

Solution

(Pentalyte Irrigation)

Each 100 mL contains: 800 mg Sodium Chloride, USP, 40 mg Potassium Chloride, USP, 20 mg

Magnesium Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium Phosphate, Heptahydrate, USP, 6.25

mg Monobasic Potassium Phosphate, NF. No antimicrobial agent has been added. pH 6.5 (4.0 to 7.0).

Osmolarity 288 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

INDICATIONS AND USAGE

Isotonic solution for irrigation only. Not for injection.

DOSAGE AND ADMINISTRATION

As directed by a physician.

Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of

warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

HOW SUPPLIED

Recommended storage: Room temperature (25°C). Avoid excessive heat.

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

2F7144

NDC 0338-0190-04

1000 mL

DIN 00800007

Baxter Logo

Not for Injection

Tis-U-Sol

Solution

(Pentalyte Irrigation)

Each 100 mL contains: 800 mg Sodium Chloride, USP,

40 mg Potassium Chloride, USP, 20 mg Magnesium

Sulfate, Heptahydrate, USP, 8.75 mg Dibasic Sodium

Phosphate, Heptahydrate, USP, 6.25 mg Monobasic

Potassium Phosphate, NF. No antimicrobial agent has

been added. pH 6.5 (4.0 to 7.0). Osmolarity 288

mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

Isotonic solution for irrigation only. Dosage and

Administration: As directed by a physician. Cautions:

Warm in oven to not more than 50°C for a maximum

of 60 days. Discard after 60 days of warming. Do not

use unless solution is clear and seal is intact. Discard

unused portion. Rx only. Recommended storage: Room

temperature (25°C). Avoid excessive heat.

PL 325 plastic

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Made in USA

Distributed in Canada by

Baxter Corporation

Mississauga, ON

L5N OC2

07-09-68-118

Bar Code Position Only*

303380190041

Carton Label

Carton Label

TIS-U-SOL Solution

(Pentalyte Irrigation)

Pour Bottle

1000 mL

NDC 0338-0190-04

2F7144

LOT #

Bar Code

(01)50303380190046(17)080630(10)G012345

TIS-U-SOL

sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate irrigant

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 338 -0 19 0

Baxter Healthcare Corporation

Route of Administration

IRRIGATION

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

SODIUM CHLORIDE

8 0 0 mg

in 10 0 mL

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 ) (POTASSIUM CATION - UNII:29 5O53K152,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

POTASSIUM CHLORIDE

40 mg

in 10 0 mL

MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8 6 9 8 T) (MAGNESIUM CATION -

UNII:T6 V3LHY8 38 )

MAGNESIUM SULFATE

HEPTAHYDRATE

20 mg

in 10 0 mL

SO DIUM PHO SPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70 WT22SF4B) (SODIUM

CATION - UNII:LYR4M0 NH37, PHOSPHATE ION - UNII:NK0 8 V8 K8 HR)

SODIUM PHOSPHATE,

DIBASIC, HEPTAHYDRATE

8 .75 mg

in 10 0 mL

PO TASSIUM PHO SPHATE, MO NO BASIC (UNII: 4J9 FJ0 HL51) (PHOSPHATE ION -

UNII:NK0 8 V8 K8 HR, POTASSIUM CATION - UNII:29 5O53K152)

POTASSIUM PHOSPHATE,

MONOBASIC

6 .25 mg

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 338 -0 19 0 -

12 in 1 CARTON

0 2/19 /19 8 2

1

10 0 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 50 8

0 2/19 /19 8 2

Labeler -

Baxter Healthcare Corporation (005083209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Baxter Healthcare

Co rpo ra tio n

0 0 1728 0 59

ANALYSIS(0 338 -0 19 0 ) , MANUFACTURE(0 338 -0 19 0 ) , LABEL(0 338 -0 19 0 ) ,

PACK(0 338 -0 19 0 ) , STERILIZE(0 338 -0 19 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Baxter Healthcare Co rpo ratio n

19 46 8 450 2

ANALYSIS(0 338 -0 19 0 )

Revised: 2/2014

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