Incontinence

Incontinence
SPL v2
SPL
SPL Set ID 78422b1a-fbb7-00a7-070f-bc9f7b8e7822
Route
ORAL
Published
Effective Date 2012-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aloe (15 [hp_X]) Silver Cation (15 [hp_C]) Arsenic Cation (3+) (3 [hp_X]) 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 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
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

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

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 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%.  

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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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

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 the involuntary loss of urine including frequency, leakage and urgency.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (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 (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 Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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