Label: ECZEMA SKIN CARE- antimon. crud., arsenicum alb., berber. vulg., bovista , bryonia , cantharis , chelidonium majus, croton, dulcamara, graphites, hepar sulph. calc., lycopodium mezereum, nux vom, petroleum, pulex irritans, pulsatilla, rhus toxicodendron, sarsaparilla, sepia, sulphur iod, 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

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

  • INDICATIONS & USAGE SECTION

    ECZEMA~SKIN CARE    Formulated for symptoms associated with seborrhea, eczema, psoriasis, cellulitis, dermatitis, lichen planus and other skin-related conditions.        

  • 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

    Antimon. crud. 20x, Arsenicum alb. 20x, Berber. vulg. 20x, Bovista 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Croton 20x, Dulcamara 20x, Graphites 20x, Hepar sulph. calc. 20x, Lycopodium 20x, Mezereum 20x, Nux vom. 20x, Petroleum 20x, Pulex irritans 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sarsaparilla 20x, Sepia 20x, Sulphur iod. 20x, Echinacea 8x, Rumex crisp. 8x, Taraxacum 8x, Urtica ur. 8x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur. 3x.                   

  • 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, 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
    ECZEMA SKIN CARE  
    antimon. crud., arsenicum alb., berber. vulg., bovista , bryonia , cantharis , chelidonium majus, croton, dulcamara, graphites, hepar sulph. calc., lycopodium mezereum, nux vom, petroleum, pulex irritans, pulsatilla, rhus toxicodendron, sarsaparilla, sepia, sulphur iod, echinacea, rumex crisp., taraxacum , urtica ur. pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide20 [hp_X]  in 1 g
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide20 [hp_X]  in 1 g
    Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark20 [hp_X]  in 1 g
    Giant Puffball (UNII: I6839Y031A) (Giant Puffball - UNII:I6839Y031A) Giant Puffball20 [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
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus20 [hp_X]  in 1 g
    Croton Tiglium Seed (UNII: 0HK2GZK66E) (Croton Tiglium Seed - UNII:0HK2GZK66E) Croton Tiglium Seed20 [hp_X]  in 1 g
    Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top20 [hp_X]  in 1 g
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite20 [hp_X]  in 1 g
    Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide20 [hp_X]  in 1 g
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore20 [hp_X]  in 1 g
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark20 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed20 [hp_X]  in 1 g
    Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene20 [hp_X]  in 1 g
    Pulex Irritans (UNII: L63DD62R8R) (Pulex Irritans - UNII:L63DD62R8R) Pulex Irritans20 [hp_X]  in 1 g
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris20 [hp_X]  in 1 g
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf20 [hp_X]  in 1 g
    Smilax Regelii Root (UNII: 2H1576D5WG) (Smilax Regelii Root - UNII:2H1576D5WG) Smilax Regelii Root20 [hp_X]  in 1 g
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice20 [hp_X]  in 1 g
    Sulfur Iodide (UNII: L6L8KA2AA0) (Sulfur Iodide - UNII:L6L8KA2AA0) Sulfur Iodide20 [hp_X]  in 1 g
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified8 [hp_X]  in 1 g
    Rumex Crispus Root (UNII: 9N1RM2S62C) (Rumex Crispus Root - UNII:9N1RM2S62C) Rumex Crispus Root8 [hp_X]  in 1 g
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale8 [hp_X]  in 1 g
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens8 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4403-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-4403-256.7 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(55714-4403)