Label: CONTROL REMEDY WATER- anacardium orientale, antimon. crud., arg. nit., berber. vulg., bryonia, chelidonium majus, digitalis, graphites, humulus, iris versicolor, solution

  • Category: HUMAN OTC 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 10, 2012

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  • Drug Facts

  • Active Ingredients

    Anacardium orientale15x
    Antimonium crudum15x
    Argentum nitricum15x
    Berberis vulgaris15x
    Bryonia15x
    Chelidonium majus15x
    Digitalis purpurea15x
    Graphites15x
    Humulus lupulus15x
    Iris versicolor15x
    Kali carbonicum15x
    Lycopodium clavatum15x
    Natrum carbonicum15x
    Natrum sulphuricum15x
    Nux vomica15x
    Pulsatilla15x
    Rhus toxicodendron15x
    Scutellaria laterifolia15x
    Sepia15x
    Stramonium15x
    Chamomilla3x
    Passiflora incarnata3x
    Valeriana officinalis3x
  • Purpose

    Formulated for symptoms associated with appetite control such as overeating, cravings, fatigue and emotional discomfort.

  • Uses

    Formulated for symptoms associated with appetite control such as overeating, cravings, fatigue and emotional discomfort.

  • Warnings

    Do not use if tamper-evident package 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.

  • Directions

    Ages 12 and up. Remedy Water® homepathic pellets are dispersed via the PowerCap® apparatus. Firmly press PowerCap® dome to release pellets into the bottle of water and shake well. Remedy Water® pellets may not dissolve completely. Drink within four hours. Avoid storing or washing where temperatures may exceed 140 degrees.

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive Ingredients

    USP/NF neutral pellets (.07% gluten-free, non-GMO, beet-derived sucrose, .03% gluten-free, non-GMO maize starch in 500 ml water)

  • Other Information

    Avoid storing in areas where temperatures may exceed 140 degrees.

  • Questions?

    1.866.777.1277
    www.RemedyWater.com

  • PRINCIPAL DISPLAY PANEL

    NDC# 35378-0006-2
     
    EssentiaLIFE Homeopathics™

    CONTROL Remedy Water®

    Formulated for symptoms associated with appetite control such as overeating, cravings, fatigue and emotional discomfort.

    Seven PowerCaps® - 1 gram each

    Directions: Ages 12 and up. Remedy Water® homepathic pellets are dispersed via the PowerCap® apparatus. Firmly press PowerCap® dome to release pellets into the bottle of water and shake well. Remedy Water® pellets may not dissolve completely. Drink within four hours. Avoid storing or washing where temperatures may exceed 140 degrees.

    IT'S ALL IN THE CAP
    NEVER A PRESERVATIVE
    1. PUSH
    2. SHAKE

    Please Recyle

    Patent Pending

    Boosted by PowerCap®

    FDA Registered and Regulated

    NO PRESERVATIVES

    ZERO CALORIES 

    BPA-FREE BOTTLE

    Active Ingredients: Anacardium orientale 15x, Antimonium crudum 15x, Argentum nitricum 15x, Berberis vulgaris 15x, Bryonia 15x, Chelidonium majus 15x,Digitalis purpurea 15x, Graphites 15x, Humulus lupulus 15x, Iris versicolor 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Natrum carbonicum 15x, Natrum sulphuricum 15x, Nux vomica 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Scutellaria lateriflora 15x, Sepia 15x, Stramonium 15x, Chamomilla 3x, Passiflora incarnate 3x, Valeriana officinalis 3x.

    Inactive ingredients: USP/NF neutral pellets (.07% gluten-free, non-GMO, beet-derived sucrose, .03% gluten-free, non-GMO maize starch in 500 ml water)

    Stock# EW03

    Lot# 01GEW03

    www.RemedyWater.com

    Distributed by EssentiaLIFE

    FDA Est.# 3006407415 Atlanta, GA 30328

    Questions?
     
    1.866.777.1277 

    Warning: Do not use if tamper-evident package 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.

    Control Water Label
  • INGREDIENTS AND APPEARANCE
    CONTROL REMEDY WATER  
    anacardium orientale, antimon. crud., arg. nit., berber. vulg., bryonia, chelidonium majus, digitalis, graphites, humulus, iris versicolor, solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35378-0006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Semecarpus Anacardium Juice (UNII: Y0F0BU8RDU) (Semecarpus Anacardium Juice - UNII:Y0F0BU8RDU) Semecarpus Anacardium Juice15 [hp_X]  in 1 mg
    Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide15 [hp_X]  in 1 mg
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mg
    Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark15 [hp_X]  in 1 mg
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mg
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mg
    Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B) Digitalis15 [hp_X]  in 1 mg
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 mg
    Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83) Hops15 [hp_X]  in 1 mg
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root15 [hp_X]  in 1 mg
    Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate15 [hp_X]  in 1 mg
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mg
    Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D) Sodium Carbonate15 [hp_X]  in 1 mg
    Sodium Sulfate (UNII: 0YPR65R21J) (Sodium Sulfate Anhydrous - UNII:36KCS0R750) Sodium Sulfate15 [hp_X]  in 1 mg
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mg
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mg
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mg
    Scutellaria Lateriflora (UNII: 7BP4DH5PDC) (Scutellaria Lateriflora - UNII:7BP4DH5PDC) Scutellaria Lateriflora15 [hp_X]  in 1 mg
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mg
    Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium15 [hp_X]  in 1 mg
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 mg
    Passiflora Incarnata Flower (UNII: K8F3G29S6Z) (Passiflora Incarnata Flower - UNII:K8F3G29S6Z) Passiflora Incarnata Flower3 [hp_X]  in 1 mg
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize1mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35378-0006-27 in 1 CONTAINER
    11000 mg in 1 CYLINDER
    2NDC:35378-0006-31 in 1 CONTAINER
    21000 mg in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2012
    Labeler - Georgetown Health, LLC DBA EssentiaLife (111513086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(35378-0006)
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