Label: SKIN - HAIR CARE- antimon. crud., arsenicum alb., azadirachta indica, berber. vulg., bovista, bryonia, cantharis, chelidonium majus, croton, dulcamara, graphites, lycopodium, mezereum, nux vom., petroleum, pulex irritans, pulsatilla, rhus toxicodendron, sulphur, echinacea, rumex crisp., taraxacum, urtica ur. liquid
SKIN-HAIR CARE- antimon. crud., arsenicum alb., azadirachta indica, berber. vulg., bovista, bryonia, cantharis, chelidonium majus, croton, dulcamara, graphites, lycopodium, mezereum, nux vom., petroleum, pulex irritans, pulsatilla, rhus toxicodendron, sulphur, echinacea, rumex crisp., taraxacum, urtica ur. liquid

  • NDC Code(s): 55714-5002-1, 55714-5002-2, 55714-5002-3, 55714-5054-1
  • Packager: Newton Laboratories, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated August 1, 2019

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  • INDICATIONS & USAGE SECTION

    Formulated for associated symptoms such as itching, swelling, skin eruptions, dry skin, hair loss, hot spots and excessive grooming. 

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Pets, under 50 lbs., give 3 drops by mouth (50 to 500 lbs. - 6 drops, over 500 lbs. - 1/2 teaspoon) as needed or as directed by a health professional. Place in mouth or purified water.

  • ACTIVE INGREDIENT SECTION

    Equal parts of Echinacea 6x, Rumex crispus 6x, Taraxacum officinale 6x, Urtica urens 6x, Antimonium crudum 15x, Arsenicum album 15x, Azadirachta indica 15x, Berberis vulgaris 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Croton tiglium 15x, Dulcamara 15x, Graphites 15x, Lycopodium clavatum 15x, Mezereum 15x, Nux vomica 15x, Petroleum 15x, Pulex irritans 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sulphur 15x. 

  • INACTIVE INGREDIENT SECTION

    USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

  • QUESTIONS SECTION

    newtonlabs.net – Questions?  800.448.7256
    Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013         

  • WARNINGS SECTION

    WARNINGS:  Keep out of reach of children.  Do not use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

  • PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a doctor before use.


  • KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    Package Label
    package label

  • INGREDIENTS AND APPEARANCE
    SKIN - HAIR CARE 
    antimon. crud., arsenicum alb., azadirachta indica, berber. vulg., bovista, bryonia, cantharis, chelidonium majus, croton, dulcamara, graphites, lycopodium, mezereum, nux vom., petroleum, pulex irritans, pulsatilla, rhus toxicodendron, sulphur, echinacea, rumex crisp., taraxacum, urtica ur. liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-5002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
    Azadirachta Indica Bark (UNII: G580B439YI) (Azadirachta Indica Bark - UNII:G580B439YI) Azadirachta Indica Bark15 [hp_X]  in 1 mL
    Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark15 [hp_X]  in 1 mL
    Lycoperdon Utriforme Fruiting Body (UNII: K2A74U428F) (Lycoperdon Utriforme Fruiting Body - UNII:K2A74U428F) Lycoperdon Utriforme Fruiting Body15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria15 [hp_X]  in 1 mL
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mL
    Croton Tiglium Seed (UNII: 0HK2GZK66E) (Croton Tiglium Seed - UNII:0HK2GZK66E) Croton Tiglium Seed15 [hp_X]  in 1 mL
    Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top15 [hp_X]  in 1 mL
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene15 [hp_X]  in 1 mL
    Pulex Irritans (UNII: L63DD62R8R) (Pulex Irritans - UNII:L63DD62R8R) Pulex Irritans15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Rumex Crispus Root (UNII: 9N1RM2S62C) (Rumex Crispus Root - UNII:9N1RM2S62C) Rumex Crispus Root3 [hp_X]  in 1 mL
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale3 [hp_X]  in 1 mL
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-5002-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-5002-3236.59 mL in 1 BOTTLE, PLASTIC
    3NDC:55714-5002-259.14 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/201107/31/2019
    SKIN-HAIR CARE 
    antimon. crud., arsenicum alb., azadirachta indica, berber. vulg., bovista, bryonia, cantharis, chelidonium majus, croton, dulcamara, graphites, lycopodium, mezereum, nux vom., petroleum, pulex irritans, pulsatilla, rhus toxicodendron, sulphur, echinacea, rumex crisp., taraxacum, urtica ur. liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-5054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
    Azadirachta Indica Bark (UNII: G580B439YI) (Azadirachta Indica Bark - UNII:G580B439YI) Azadirachta Indica Bark15 [hp_X]  in 1 mL
    Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark15 [hp_X]  in 1 mL
    Lycoperdon Utriforme Fruiting Body (UNII: K2A74U428F) (Lycoperdon Utriforme Fruiting Body - UNII:K2A74U428F) Lycoperdon Utriforme Fruiting Body15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria15 [hp_X]  in 1 mL
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mL
    Croton Tiglium Seed (UNII: 0HK2GZK66E) (Croton Tiglium Seed - UNII:0HK2GZK66E) Croton Tiglium Seed15 [hp_X]  in 1 mL
    Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top15 [hp_X]  in 1 mL
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene15 [hp_X]  in 1 mL
    Pulex Irritans (UNII: L63DD62R8R) (Pulex Irritans - UNII:L63DD62R8R) Pulex Irritans15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified6 [hp_X]  in 1 mL
    Rumex Crispus Root (UNII: 9N1RM2S62C) (Rumex Crispus Root - UNII:9N1RM2S62C) Rumex Crispus Root6 [hp_X]  in 1 mL
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale6 [hp_X]  in 1 mL
    Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-5054-130 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2019
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE, API MANUFACTURE
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