Incontinence
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:10
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
Contacts and useful links#
Websitewww.newtonlabs.net
www.newtonlabs.net
www.newtonlabs.netLabel contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Incontinence Formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.
ACTIVE INGREDIENT SECTION
Aloe 20x, Arg. nit. 20x, Arsenicum alb. 20x, Belladonna 20x, Benzoicum acidum 20x, Bryonia 20x, Cantharis 20x, Causticum 20x, Equisetum hyemale 20x, Ferrum metallicum 20x, Gelsemium 20x, Ignatia 20x, Kali phos. 20x, Lycopodium 20x, Nat. mur. 20x, Nitricum ac. 20x, Plantago 20x, Pulsatilla 20x, Rhus aromatica 20x, Sabal 20x, Secale 20x, Sepia 20x, Staphysag. 20x, Stramonium 20x, Thyroidinum 20x, Verbascum 20x, Echinacea 8x, Hydrastis 8x, Echinacea 3x, Hydrastis 3x.
PURPOSE SECTION
Formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
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.
PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.
KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4535-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-22ae-f424-e053-dadaa90a57ce | Incontinence |
| 55714-4535-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-22ae-f424-e053-dadaa90a57ce | Incontinence |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4535-1 | Incontinence | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-4535-2 | Incontinence | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4535 | INCONTINENCE (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) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20131107_e454495f-a832-1d19-fcb4-538c382189f9.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Aloe | ACTIVE INGREDIENT | V5VD430YW9 | 1 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 1 | |
| Atropa Belladonna | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| Benzoic Acid | ACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Causticum | ACTIVE INGREDIENT | DD5FO1WKFU | 1 | |
| Claviceps Purpurea Sclerotium | ACTIVE INGREDIENT | 01G9XEA93N | 1 | |
| Datura Stramonium | ACTIVE INGREDIENT | G6W4F0V8Z3 | 1 | |
| Delphinium Staphisagria Seed | ACTIVE INGREDIENT | 00543AP1JV | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| Equisetum Hyemale | ACTIVE INGREDIENT | 59677RXH25 | 1 | |
| Gelsemium Sempervirens Root | ACTIVE INGREDIENT | 639KR60Q1Q | 1 | |
| Goldenseal | ACTIVE INGREDIENT | ZW3Z11D0JV | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 1 | |
| Lytta Vesicatoria | ACTIVE INGREDIENT | 3Q034RO3BT | 1 | |
| Nitric Acid | ACTIVE INGREDIENT | 411VRN1TV4 | 1 | |
| Plantago Major | ACTIVE INGREDIENT | W2469WNO6U | 1 | |
| Potassium Phosphate, Dibasic | ACTIVE INGREDIENT | CI71S98N1Z | 1 | |
| Pulsatilla Vulgaris | ACTIVE INGREDIENT | I76KB35JEV | 1 | |
| Rhus Aromatica Root Bark | ACTIVE INGREDIENT | Q3H36W0J42 | 1 | |
| Saw Palmetto | ACTIVE INGREDIENT | J7WWH9M8QS | 1 | |
| Sepia Officinalis Juice | ACTIVE INGREDIENT | QDL83WN8C2 | 1 | |
| Silver Nitrate | ACTIVE INGREDIENT | 95IT3W8JZE | 1 | |
| Sodium Chloride | ACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| Strychnos Ignatii Seed | ACTIVE INGREDIENT | 1NM3M2487K | 1 | |
| Thyroid, Unspecified | ACTIVE INGREDIENT | 0B4FDL9I6P | 1 | |
| Verbascum Thapsus | ACTIVE INGREDIENT | C9TD27U172 | 1 | |
| Aloe | ACTIVE MOIETY | V5VD430YW9 | 1 | |
| Arsenic Cation (3+) | ACTIVE MOIETY | C96613F5AV | 1 | |
| Atropa Belladonna | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| Benzoic Acid | ACTIVE MOIETY | 8SKN0B0MIM | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Causticum | ACTIVE MOIETY | DD5FO1WKFU | 1 | |
| Chloride Ion | ACTIVE MOIETY | Q32ZN48698 | 1 | |
| Claviceps Purpurea Sclerotium | ACTIVE MOIETY | 01G9XEA93N | 1 | |
| Datura Stramonium | ACTIVE MOIETY | G6W4F0V8Z3 | 1 | |
| Delphinium Staphisagria Seed | ACTIVE MOIETY | 00543AP1JV | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| Equisetum Hyemale | ACTIVE MOIETY | 59677RXH25 | 1 | |
| Gelsemium Sempervirens Root | ACTIVE MOIETY | 639KR60Q1Q | 1 | |
| Goldenseal | ACTIVE MOIETY | ZW3Z11D0JV | 1 | |
| Iron | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 1 | |
| Lytta Vesicatoria | ACTIVE MOIETY | 3Q034RO3BT | 1 | |
| Nitric Acid | ACTIVE MOIETY | 411VRN1TV4 | 1 | |
| Phosphate Ion | ACTIVE MOIETY | NK08V8K8HR | 1 | |
| Plantago Major | ACTIVE MOIETY | W2469WNO6U | 1 | |
| Pulsatilla Vulgaris | ACTIVE MOIETY | I76KB35JEV | 1 | |
| Rhus Aromatica Root Bark | ACTIVE MOIETY | Q3H36W0J42 | 1 | |
| Saw Palmetto | ACTIVE MOIETY | J7WWH9M8QS | 1 | |
| Sepia Officinalis Juice | ACTIVE MOIETY | QDL83WN8C2 | 1 | |
| Silver Cation | ACTIVE MOIETY | 57N7B0K90A | 1 | |
| Strychnos Ignatii Seed | ACTIVE MOIETY | 1NM3M2487K | 1 | |
| Thyroid, Unspecified | ACTIVE MOIETY | 0B4FDL9I6P | 1 | |
| Verbascum Thapsus | ACTIVE MOIETY | C9TD27U172 | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Incontinence
- 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
- Aloe
- Silver Nitrate
- Silver Cation
- Arsenic Trioxide
- Arsenic Cation (3+)
- Atropa Belladonna
- Benzoic Acid
- Bryonia Alba Root
- Lytta Vesicatoria
- Causticum
- Equisetum Hyemale
- Iron
- Gelsemium Sempervirens Root
- Strychnos Ignatii Seed
- Potassium Phosphate, Dibasic
- Phosphate Ion
- Lycopodium Clavatum Spore
- Sodium Chloride
- Chloride Ion
- 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
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4535 | 55714-4535-1, 55714-4535-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5f134a6e-33a9-a70a-b9b2-b18fedd1aac7 | e454495f-a832-1d19-fcb4-538c382189f9 | 2011-06-01 | Warnings | 5f134a6e-33a9-a70a-b9b2-b18fedd1aac7 e454495f-a832-1d19-fcb4-538c382189f9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.