Label: POISON IVY- xerophyllum asphodeloides, aconitum nap., anacardium occidentale, apis mel., bryonia, cantharis, croton, graphites, grindelia, mezereum, nux vom., ranunc. bulb., rhus toxicodendron, sarsaparilla, sulphur, echinacea, rumex crisp., taraxacum, urtica ur. 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

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  • INDICATIONS & USAGE SECTION

    Poison Ivy  Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

  • DOSAGE & ADMINISTRATION SECTION

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

  • ACTIVE INGREDIENT SECTION

    Xerophyllum asphodeloides 30x, Aconitum nap. 15x, Anacardium occidentale 15x, Apis mel. 15x, Bryonia 15x, Cantharis 15x, Croton 15x, Graphites 15x, Grindelia 15x, Mezereum 15x, Nux vom. 15x, Ranunc. bulb. 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sulphur 15x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur. 3x.

  • PURPOSE SECTION

    Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

  • INACTIVE INGREDIENT SECTION

    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, 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
    package label

  • INGREDIENTS AND APPEARANCE
    POISON IVY  
    xerophyllum asphodeloides, aconitum nap., anacardium occidentale, apis mel., bryonia, cantharis, croton, graphites, grindelia, mezereum, nux vom., ranunc. bulb., rhus toxicodendron, sarsaparilla, sulphur, echinacea, rumex crisp., taraxacum, urtica ur. pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4477
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Xerophyllum Asphodeloides (UNII: 9I4XB1GP2B) (Xerophyllum Asphodeloides - UNII:9I4XB1GP2B) Xerophyllum Asphodeloides30 [hp_X]  in 1 g
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus15 [hp_X]  in 1 g
    Anacardium Occidentale Fruit (UNII: 4A10JR4E7E) (Anacardium Occidentale Fruit - UNII:4A10JR4E7E) Anacardium Occidentale Fruit15 [hp_X]  in 1 g
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 g
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 g
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria15 [hp_X]  in 1 g
    Croton Tiglium Seed (UNII: 0HK2GZK66E) (Croton Tiglium Seed - UNII:0HK2GZK66E) Croton Tiglium Seed15 [hp_X]  in 1 g
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 g
    Grindelia Hirsutula Flowering Top (UNII: IDB0NAZ6AI) (Grindelia Hirsutula Flowering Top - UNII:IDB0NAZ6AI) Grindelia Hirsutula Flowering Top15 [hp_X]  in 1 g
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 g
    Ranunculus Bulbosus (UNII: AEQ8NXJ0MB) (Ranunculus Bulbosus - UNII:AEQ8NXJ0MB) Ranunculus Bulbosus15 [hp_X]  in 1 g
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 g
    Smilax Regelii Root (UNII: 2H1576D5WG) (Smilax Regelii Root - UNII:2H1576D5WG) Smilax Regelii Root15 [hp_X]  in 1 g
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 g
    Rumex Crispus Root (UNII: 9N1RM2S62C) (Rumex Crispus Root - UNII:9N1RM2S62C) Rumex Crispus Root3 [hp_X]  in 1 g
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale3 [hp_X]  in 1 g
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens3 [hp_X]  in 1 g
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur15 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4477-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-4477-256.7 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-4477)
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