MedPath
FDA Product

Ustell

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Ustell

0076-0903

Regulatory Information

0076-0903

January 10, 2017

Ustell™

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

962184003

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

METHENAMINE

Quantity: 120 mg in 1 1

Code: J50OIX95QV

Class Code: ACTIB

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Quantity: 40.8 mg in 1 1

Code: 593YOG76RN

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

PHENYL SALICYLATE

Quantity: 36 mg in 1 1

Code: 28A37T47QO

Class Code: ACTIB

METHYLENE BLUE

Quantity: 10 mg in 1 1

Code: T42P99266K

Class Code: ACTIB

HYOSCYAMINE SULFATE

Quantity: 0.12 mg in 1 1

Code: F2R8V82B84

Class Code: ACTIB

Active Moieties

SODIUM CATION

Code: LYR4M0NH37

PHENYL SALICYLATE

Code: 28A37T47QO

HYOSCYAMINE

Code: PX44XO846X

METHENAMINE

Code: J50OIX95QV

METHYLENE BLUE CATION

Code: ZMZ79891ZH

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