MedPath
FDA Product

UroAv-B

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

Basic Information

UroAv-B

15338-503

Regulatory Information

15338-503

May 21, 2018

UroAv-B Urinary Antiseptic (Product contract packaged by Apace Packaging, LLC)

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

361961142

Active Ingredients

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

LACTOSE, UNSPECIFIED FORM

Code: J2B2A4N98G

Class Code: IACT

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

METHENAMINE

Quantity: 118 mg in 1 1

Code: J50OIX95QV

Class Code: ACTIB

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

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

Quantity: 40.8 mg in 1 1

Code: KH7I04HPUU

Class Code: ACTIB

Active Moieties

PHENYL SALICYLATE

Code: 28A37T47QO

METHYLENE BLUE CATION

Code: ZMZ79891ZH

METHENAMINE

Code: J50OIX95QV

SODIUM CATION

Code: LYR4M0NH37

HYOSCYAMINE

Code: PX44XO846X

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