Incontinence 4748l

Incontinence 4748l
SPL v3
SPL
SPL Set ID 994cbc8e-a221-1548-e053-2995a90a1f7f
Route
ORAL
Published
Effective Date 2025-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aloe (15 [hp_X]) Silver Cation (6 [hp_X]) Arsenic Cation (3+) Atropa Belladonna Benzoic Acid Bryonia Alba Root Lytta Vesicatoria Causticum Equisetum Hyemale Iron Gelsemium Sempervirens Root Strychnos Ignatii Seed Phosphate Ion Lycopodium Clavatum Spore 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
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.

Purpose

Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.


Medication Information

Purpose

Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.

Description

Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.

Package Label

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

Questions Section

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

Questions?  1.800.448.7256

Otc Purpose Section

Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms associated with various types of incontinence such as frequency, leakage and urgency.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

Otc Active Ingredient Section (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 Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)