Tis-u-sol irrigant

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 50C 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 (25C). Avoid excessive heat.

Ingredients and appearance - Product information

Tis-u-sol irrigant- Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0338-0190
Route of Administration Irrigation

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium chloride ( UNII: 451W47IQ8X)( Sodium cation - UNII: LYR4M0NH37 ) 800 mgin 100 mL
Potassium chloride ( UNII: 660YQ98I10)( Potassium cation - UNII: 295O53K152 ) 40 mgin 100 mL
Magnesium sulfate heptahydrate ( UNII: SK47B8698T)( Magnesium cation - UNII: T6V3LHY838 ) 20 mgin 100 mL
Sodium phosphate, dibasic, heptahydrate ( UNII: 70WT22SF4B)( Sodium cation - UNII: LYR4M0NH37 ) 8.75 mgin 100 mL
Potassium phosphate, monobasic ( UNII: 4J9FJ0HL51)( Phosphate ion - UNII: NK08V8K8HR ) 6.25 mgin 100 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA018508 USA

Labeler - Baxter Healthcare Corporation( 005083209)

Establishment

Name ID/FEI Business Operations
Baxter Healthcare Corporation 005083209 ANALYSIS( 0338-0190), MANUFACTURE( 0338-0190), LABEL( 0338-0190), PACK( 0338-0190), STERILIZE( 0338-0190)

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 50C 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 (25C). 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

LOT
EXP

Carton Label

Carton Label

TIS-U-SOL ®Solution
(Pentalyte Irrigation)
Pour Bottle

1000 mL

Qty
12

NDC 0338-0190-04
2F7144

EXP
LOT #

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