Label: SKIN 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): 55714-4289-0, 55714-4289-1, 55714-4289-2, 55714-4296-1
- 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 January 14, 2019
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Rumex crisp. 6x, Taraxacum 6x, Urtica ur. 6x, Antimon. crud. 15x, Arsenicum alb. 15x, Azadirachta indica 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irritans 15x, Pulsatilla 15x, Rhus toxi. 15x, Sulphur 15x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
newtonlabs.net Questions? 1.800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL.
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INGREDIENTS AND APPEARANCE
SKIN 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. liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-4289 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide 15 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X] in 1 mL Azadirachta Indica Bark (UNII: G580B439YI) (Azadirachta Indica Bark - UNII:G580B439YI) Azadirachta Indica Bark 15 [hp_X] in 1 mL Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark 15 [hp_X] in 1 mL Giant Puffball (UNII: I6839Y031A) (Giant Puffball - UNII:I6839Y031A) Giant Puffball 15 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X] in 1 mL Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 15 [hp_X] in 1 mL Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 15 [hp_X] in 1 mL Croton Tiglium Seed (UNII: 0HK2GZK66E) (Croton Tiglium Seed - UNII:0HK2GZK66E) Croton Tiglium Seed 15 [hp_X] in 1 mL Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top 15 [hp_X] in 1 mL Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite 15 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 mL Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark 15 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 15 [hp_X] in 1 mL Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene 15 [hp_X] in 1 mL Pulex Irritans (UNII: L63DD62R8R) (Pulex Irritans - UNII:L63DD62R8R) Pulex Irritans 15 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 15 [hp_X] in 1 mL Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 15 [hp_X] in 1 mL Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 15 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 mL Rumex Crispus Root (UNII: 9N1RM2S62C) (Rumex Crispus Root - UNII:9N1RM2S62C) Rumex Crispus Root 3 [hp_X] in 1 mL Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale 3 [hp_X] in 1 mL Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4289-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-4289-2 59.14 mL in 1 BOTTLE, GLASS 3 NDC:55714-4289-0 14.78 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/15/2011 12/31/2018 SKIN 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. liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-4296 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide 15 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X] in 1 mL Azadirachta Indica Bark (UNII: G580B439YI) (Azadirachta Indica Bark - UNII:G580B439YI) Azadirachta Indica Bark 15 [hp_X] in 1 mL Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark 15 [hp_X] in 1 mL Giant Puffball (UNII: I6839Y031A) (Giant Puffball - UNII:I6839Y031A) Giant Puffball 15 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X] in 1 mL Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 15 [hp_X] in 1 mL Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 15 [hp_X] in 1 mL Croton Tiglium Seed (UNII: 0HK2GZK66E) (Croton Tiglium Seed - UNII:0HK2GZK66E) Croton Tiglium Seed 15 [hp_X] in 1 mL Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top 15 [hp_X] in 1 mL Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite 15 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 mL Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark 15 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 15 [hp_X] in 1 mL Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene 15 [hp_X] in 1 mL Pulex Irritans (UNII: L63DD62R8R) (Pulex Irritans - UNII:L63DD62R8R) Pulex Irritans 15 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 15 [hp_X] in 1 mL Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 15 [hp_X] in 1 mL Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 15 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 6 [hp_X] in 1 mL Rumex Crispus Root (UNII: 9N1RM2S62C) (Rumex Crispus Root - UNII:9N1RM2S62C) Rumex Crispus Root 6 [hp_X] in 1 mL Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale 6 [hp_X] in 1 mL Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4296-1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/14/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE, API MANUFACTURE