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, goldenseal, 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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PRODUCT NAME & INDICATIONS SECTION

INCONTINENCE   Formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.         

DIRECTION 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.              

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:  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 or 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

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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4534
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aloe (Aloe) Aloe20 [hp_X]  in 1 mL
Silver Nitrate (Silver Cation) Silver Nitrate20 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide20 [hp_X]  in 1 mL
Atropa Belladonna (Atropa Belladonna) Atropa Belladonna20 [hp_X]  in 1 mL
Benzoic Acid (Benzoic Acid) Benzoic Acid20 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root20 [hp_X]  in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria20 [hp_X]  in 1 mL
Causticum (Causticum) Causticum20 [hp_X]  in 1 mL
Equisetum Hyemale (Equisetum Hyemale) Equisetum Hyemale20 [hp_X]  in 1 mL
Iron (Iron) Iron20 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root20 [hp_X]  in 1 mL
Strychnos Ignatii Seed (Strychnos Ignatii Seed) Strychnos Ignatii Seed20 [hp_X]  in 1 mL
Potassium Phosphate, Dibasic (Phosphate Ion) Potassium Phosphate, Dibasic20 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore) Lycopodium Clavatum Spore20 [hp_X]  in 1 mL
Sodium Chloride (Sodium Cation) Sodium Chloride20 [hp_X]  in 1 mL
Nitric Acid (Nitric Acid) Nitric Acid20 [hp_X]  in 1 mL
Plantago Major (Plantago Major) Plantago Major20 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris20 [hp_X]  in 1 mL
Rhus Aromatica Root Bark (Rhus Aromatica Root Bark) Rhus Aromatica Root Bark20 [hp_X]  in 1 mL
Saw Palmetto (Saw Palmetto) Saw Palmetto20 [hp_X]  in 1 mL
Claviceps Purpurea Sclerotium (Claviceps Purpurea Sclerotium) Claviceps Purpurea Sclerotium20 [hp_X]  in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice) Sepia Officinalis Juice20 [hp_X]  in 1 mL
Delphinium Staphisagria Seed (Delphinium Staphisagria Seed) Delphinium Staphisagria Seed20 [hp_X]  in 1 mL
Datura Stramonium (Datura Stramonium) Datura Stramonium20 [hp_X]  in 1 mL
Thyroid, Unspecified (Thyroid, Unspecified) Thyroid, Unspecified20 [hp_X]  in 1 mL
Verbascum Thapsus (Verbascum Thapsus) Verbascum Thapsus20 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified8 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal8 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-4534-129.57 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4534), API MANUFACTURE(55714-4534)

Revised: 06/2011
 
Newton Laboratories, Inc.