Physiosol

Basic Information

Product Name

Physiosol

FDA Product Code

0990-6141

Regulatory Information

NDC Product Code

0990-6141

Application Number

NDA017637

Marketing Category

C73594

Effective Date

January 6, 2022

Territorial Authority

USA

FDA Title

PHYSIOSOL IRRIGATION

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM ACETATE ANHYDROUS

Quantity: 222 mg in 100 mL

Code: NVG71ZZ7P0

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 526 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

SODIUM GLUCONATE

Quantity: 502 mg in 100 mL

Code: R6Q3791S76

Class Code: ACTIB

POTASSIUM CHLORIDE

Quantity: 37 mg in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

MAGNESIUM CHLORIDE

Quantity: 30 mg in 100 mL

Code: 02F3473H9O

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

SODIUM CATION

Code: LYR4M0NH37

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

HYDROCHLORIC ACID

Active Moieties

CHLORIDE ION

SODIUM CATION