FDA.reportPublic FDA data

Bladder Incontinence

Manufacturer
King Bio Inc.
Effective date
2012-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:49

Label at a glance#

ProductBladder Incontinence
Active ingredientATROPA BELLADONNA, BELLIS PERENNIS, BENZOIC ACID, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA ROOT BARK, SEPIA OFFICINALIS JUICE
Label structure8 sections

Indications and uses

Uses for temporary relief of symptoms: involuntary urination, urinary leakage with strain, sneeze or laughter, frequent urination, burning while urinating and associated back pain. Reference image bladderincontinence.jpg

Dosage and administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed. Adult Dose 3 pump sprays Children 2 - 12 years 2 pump sprays Reference image badderincontinence.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Belladonna, Bellis perennis, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia.

Reference image bladderincontinence.jpg

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.


Reference image bladderincontinence.jpg

Purpose

OTC - PURPOSE SECTION

Uses for temporary relief of symptoms:

  • involuntary urination
  • urinary leakage with strain, sneeze or laughter
  • frequent urination
  • burning while urinating
  • associated back pain
Reference image bladderincontinence.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed.

Adult Dose 3 pump sprays

Children 2 - 12 years 2 pump sprays

Reference image badderincontinence.jpg

Warnings

WARNINGS SECTION

If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Other: Tamper resistant for your protection. Use only if safety seal is intact.

Reference image bladderincontinence.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Reference image bladderincontinence.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses for temporary relief of symptoms: involuntary urination, urinary leakage with strain, sneeze or laughter, frequent urination, burning while urinating and associated back pain.

Reference image bladderincontinence.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of label
Image of label


King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5045-22020-01-31C16284748780-19d75b9cf-e819-f424-e053-dadaa90a57ceBladder Incontinence

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5045-2Bladder Incontinence59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5045BLADDER INCONTINENCE (BELLADONNA, BELLIS PERENNIS, BENZOICUM ACIDUM, CAUSTICUM, EQUISETUM HYEMALE, LYCOPODIUM CLAVATUM, PHOSPHORUS, PLANTAGO MAJOR, RHUS AROMATICA, SEPIA) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20120620_359d5d36-ae00-4078-94fd-8d668d971867.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UY1
BENZOIC ACIDACTIVE INGREDIENT8SKN0B0MIM1
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU1
EQUISETUM HYEMALEACTIVE INGREDIENT59677RXH251
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U1
RHUS AROMATICA ROOT BARKACTIVE INGREDIENTQ3H36W0J421
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
BELLIS PERENNISACTIVE MOIETY2HU33I03UY1
BENZOIC ACIDACTIVE MOIETY8SKN0B0MIM1
CAUSTICUMACTIVE MOIETYDD5FO1WKFU1
EQUISETUM HYEMALEACTIVE MOIETY59677RXH251
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U1
RHUS AROMATICA ROOT BARKACTIVE MOIETYQ3H36W0J421
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-504557955-5045-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BELLIS PERENNIS2HU33I03UYACTIB
BENZOIC ACID8SKN0B0MIMACTIB
CAUSTICUMDD5FO1WKFUACTIB
EQUISETUM HYEMALE59677RXH25ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PHOSPHORUS27YLU75U4WACTIB
PLANTAGO MAJORW2469WNO6UACTIB
RHUS AROMATICA ROOT BARKQ3H36W0J42ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c059e92b-4246-4acc-b3b5-4236b9f61fa3359d5d36-ae00-4078-94fd-8d668d9718672012-06-19WarningsExact identifier
spl id: c059e92b-4246-4acc-b3b5-4236b9f61fa3
spl set id: 359d5d36-ae00-4078-94fd-8d668d971867

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.