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 pellet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated June 1, 2011

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE SECTION

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

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.              

  • 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:  Gluten-free, non-GMO, beet-derived sucrose pellets.       

  • 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.    

  • 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.           

  • KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.       

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    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
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4535
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe20 [hp_X]  in 1 g
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate20 [hp_X]  in 1 g
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide20 [hp_X]  in 1 g
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna20 [hp_X]  in 1 g
    Benzoic Acid (UNII: 8SKN0B0MIM) (Benzoic Acid - UNII:8SKN0B0MIM) Benzoic Acid20 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root20 [hp_X]  in 1 g
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria20 [hp_X]  in 1 g
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum20 [hp_X]  in 1 g
    Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25) Equisetum Hyemale20 [hp_X]  in 1 g
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron20 [hp_X]  in 1 g
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root20 [hp_X]  in 1 g
    Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed20 [hp_X]  in 1 g
    Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR) Potassium Phosphate, Dibasic20 [hp_X]  in 1 g
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore20 [hp_X]  in 1 g
    Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride20 [hp_X]  in 1 g
    Nitric Acid (UNII: 411VRN1TV4) (Nitric Acid - UNII:411VRN1TV4) Nitric Acid20 [hp_X]  in 1 g
    Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major20 [hp_X]  in 1 g
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris20 [hp_X]  in 1 g
    Rhus Aromatica Root Bark (UNII: Q3H36W0J42) (Rhus Aromatica Root Bark - UNII:Q3H36W0J42) Rhus Aromatica Root Bark20 [hp_X]  in 1 g
    Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto20 [hp_X]  in 1 g
    Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium20 [hp_X]  in 1 g
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice20 [hp_X]  in 1 g
    Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed20 [hp_X]  in 1 g
    Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium20 [hp_X]  in 1 g
    Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P) Thyroid, Unspecified20 [hp_X]  in 1 g
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus20 [hp_X]  in 1 g
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified8 [hp_X]  in 1 g
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal8 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4535-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-4535-256.7 g 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(55714-4535)