Incontinence

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:48

Label at a glance#

ProductIncontinence
Active ingredientAloe, Silver Nitrate, Arsenic Trioxide, Atropa Belladonna, Benzoic Acid, Bryonia Alba Root, Lytta Vesicatoria, Causticum, Equisetum Hyemale, Iron, Gelsemium Sempervirens Root, Strychnos Ignatii Seed, Potassium Phosphate, Dibasic, Lycopodium Clavatum Spore, Sodium Chloride, Nitric Acid, Plantago Major, Pulsatilla Vulgaris, Rhus Aromatica Root Bark, Saw Palmetto, Claviceps Purpurea Sclerotium, Sepia Officinalis Juice, Delphinium Staphisagria Seed, Datura Stramonium, Thyroid, Unspecified, Verbascum Thapsus, Echinacea, Unspecified, Goldenseal
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Incontinence    Formulated for symptoms associated with the involuntary loss of urine including frequency, leakage and urgency.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aloe 15x, Arg. nit. 15x, Arsenicum alb.15x, Belladonna 15x, Benzoicum acidum 15x, Bryonia 15x, Cantharis 15x, Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium 15x, Ignatia 15x, Kali phos. 15x, Lycopodium 15x, Nat. mur. 15x, Nitricum ac. 15x, Plantago 15x, Pulsatilla 15x, Rhus aromatica 15x, Sabal 15x, Secale 15x, Sepia 15x, Staphysag. 15x, Stramonium 15x, Thyroidinum 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with the involuntary loss of urine including frequency, leakage and urgency.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2286-02020-01-31C16284748780-19d75b9d0-9784-f424-e053-dadaa90a57ceIncontinence
55714-2286-12020-01-31C16284748780-19d75b9d0-9784-f424-e053-dadaa90a57ceIncontinence
55714-2286-22020-01-31C16284748780-19d75b9d0-9784-f424-e053-dadaa90a57ceIncontinence

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2286-0Incontinence.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2286-1Incontinence29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2286-2Incontinence59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2286INCONTINENCE (ALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTIS) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130806_78422b1a-fbb7-00a7-070f-bc9f7b8e7822.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AloeACTIVE INGREDIENTV5VD430YW92
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H2
Benzoic AcidACTIVE INGREDIENT8SKN0B0MIM2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
CausticumACTIVE INGREDIENTDD5FO1WKFU2
Claviceps Purpurea SclerotiumACTIVE INGREDIENT01G9XEA93N2
Datura StramoniumACTIVE INGREDIENTG6W4F0V8Z32
Delphinium Staphisagria SeedACTIVE INGREDIENT00543AP1JV2
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Equisetum HyemaleACTIVE INGREDIENT59677RXH252
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q2
GoldensealACTIVE INGREDIENTZW3Z11D0JV2
IronACTIVE INGREDIENTE1UOL152H72
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT2
Nitric AcidACTIVE INGREDIENT411VRN1TV42
Plantago MajorACTIVE INGREDIENTW2469WNO6U2
Potassium Phosphate, DibasicACTIVE INGREDIENTCI71S98N1Z2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Rhus Aromatica Root BarkACTIVE INGREDIENTQ3H36W0J422
Saw PalmettoACTIVE INGREDIENTJ7WWH9M8QS2
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Silver NitrateACTIVE INGREDIENT95IT3W8JZE2
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X2
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K2
Thyroid, UnspecifiedACTIVE INGREDIENT0B4FDL9I6P2
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1722
AloeACTIVE MOIETYV5VD430YW92
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H2
Benzoic AcidACTIVE MOIETY8SKN0B0MIM2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
CausticumACTIVE MOIETYDD5FO1WKFU2
Chloride IonACTIVE MOIETYQ32ZN486982
Claviceps Purpurea SclerotiumACTIVE MOIETY01G9XEA93N2
Datura StramoniumACTIVE MOIETYG6W4F0V8Z32
Delphinium Staphisagria SeedACTIVE MOIETY00543AP1JV2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Equisetum HyemaleACTIVE MOIETY59677RXH252
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q2
GoldensealACTIVE MOIETYZW3Z11D0JV2
IronACTIVE MOIETYE1UOL152H72
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT2
Nitric AcidACTIVE MOIETY411VRN1TV42
Phosphate IonACTIVE MOIETYNK08V8K8HR2
Plantago MajorACTIVE MOIETYW2469WNO6U2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Rhus Aromatica Root BarkACTIVE MOIETYQ3H36W0J422
Saw PalmettoACTIVE MOIETYJ7WWH9M8QS2
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Silver CationACTIVE MOIETY57N7B0K90A2
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K2
Thyroid, UnspecifiedACTIVE MOIETY0B4FDL9I6P2
Verbascum ThapsusACTIVE MOIETYC9TD27U1722
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-228655714-2286-1, 55714-2286-2, 55714-2286-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
f1c3d3a2-259d-4e89-0b9b-e159bacf90e278422b1a-fbb7-00a7-070f-bc9f7b8e78222011-03-01WarningsExact identifier
spl id: f1c3d3a2-259d-4e89-0b9b-e159bacf90e2
spl set id: 78422b1a-fbb7-00a7-070f-bc9f7b8e7822

Reported adverse events (FAERS/openFDA)#

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