INCONTINENCE - aloe, 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 and goldenseal liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

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

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 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2286
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aloe (Aloe)	Aloe	15 [hp_X] in 1 mL
Silver Nitrate (Silver Cation)	Silver Nitrate	15 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	15 [hp_X] in 1 mL
Atropa Belladonna (Atropa Belladonna)	Atropa Belladonna	15 [hp_X] in 1 mL
Benzoic Acid (Benzoic Acid)	Benzoic Acid	15 [hp_C] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria)	Lytta Vesicatoria	15 [hp_X] in 1 mL
Causticum (Causticum)	Causticum	15 [hp_X] in 1 mL
Equisetum Hyemale (Equisetum Hyemale)	Equisetum Hyemale	15 [hp_X] in 1 mL
Iron (Iron)	Iron	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Strychnos Ignatii Seed (Strychnos Ignatii Seed)	Strychnos Ignatii Seed	15 [hp_X] in 1 mL
Potassium Phosphate, Dibasic (Phosphate Ion)	Potassium Phosphate, Dibasic	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Sodium Chloride (Chloride Ion)	Sodium Chloride	15 [hp_X] in 1 mL
Nitric Acid (Nitric Acid)	Nitric Acid	15 [hp_X] in 1 mL
Plantago Major (Plantago Major)	Plantago Major	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris)	Pulsatilla Vulgaris	15 [hp_X] in 1 mL
Rhus Aromatica Root Bark (Rhus Aromatica Root Bark)	Rhus Aromatica Root Bark	15 [hp_X] in 1 mL
Saw Palmetto (Saw Palmetto)	Saw Palmetto	15 [hp_X] in 1 mL
Claviceps Purpurea Sclerotium (Claviceps Purpurea Sclerotium)	Claviceps Purpurea Sclerotium	15 [hp_X] in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice)	Sepia Officinalis Juice	15 [hp_X] in 1 mL
Delphinium Staphisagria Seed (Delphinium Staphisagria Seed)	Delphinium Staphisagria Seed	15 [hp_X] in 1 mL
Datura Stramonium (Datura Stramonium)	Datura Stramonium	15 [hp_X] in 1 mL
Thyroid, Unspecified (Thyroid, Unspecified)	Thyroid, Unspecified	15 [hp_X] in 1 mL
Verbascum Thapsus (Verbascum Thapsus)	Verbascum Thapsus	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL
Goldenseal (Goldenseal)	Goldenseal	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2286-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2286-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2286-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	LABEL(55714-2286), API MANUFACTURE(55714-2286)

Revised: 03/2011

Document Id: 342bc4a9-a342-17f0-b11b-66d409f0cb48

Set id: 78422b1a-fbb7-00a7-070f-bc9f7b8e7822

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.