Incontinence
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-02-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:31:51
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, ANEMONE PULSATILLA, 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#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for symptoms associated with the involuntary loss of urine including frequency, leakage and urgency.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis canadensis 6x,Aloe 15x, Argentum nitricum 15x, Arsenicum album 15x, Belladonna 15x, Benzoicum acidum 15x, Bryonia 15x, Cantharis 15x, Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium sempervirens 15x, Ignatia amara 15x, Kali phosphoricum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Nitricum acidum 15x, Plantago major 15x, Pulsatilla 15x, Rhus aromatica 15x, Sabal serrulata 15x, Secale cornutum 15x, Sepia 15x, Staphysagria 15x, Stramonium 15x, Thyroidinum 15x, Verbascum thapsus 15x.
OTC - PURPOSE SECTION
Formulated for symptoms associated with the involuntary loss of urine including frequency, leakage and urgency.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
QUESTIONS SECTION
newtonlabs.net – Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
WARNINGS SECTION
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2464-1 | Incontinence | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2464 | 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.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250210_9c0d8c82-6c4f-a511-e053-2995a90a793f.zip |
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
- SUCROSE
- SODIUM CHLORIDE
- CHLORIDE ION
- NITRIC ACID
- PLANTAGO MAJOR
- ANEMONE PULSATILLA
- RHUS AROMATICA ROOT BARK
- SAW PALMETTO
- CLAVICEPS PURPUREA SCLEROTIUM
- SEPIA OFFICINALIS JUICE
- DELPHINIUM STAPHISAGRIA SEED
- DATURA STRAMONIUM
- THYROID, UNSPECIFIED
- VERBASCUM THAPSUS
- ECHINACEA, UNSPECIFIED
- GOLDENSEAL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2464 | 55714-2464-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| 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 | Newton Laboratories, Inc. | 9c0d8c82-6c4f-a511-e053-2995a90a793f | 2025-02-07 | Warnings | 55714-2464-1 55714-2464 55714246401 2d92862e-4bec-1df9-e063-6394a90a6ac9 9c0d8c82-6c4f-a511-e053-2995a90a793f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.