NDC | 55714-4339-0, 55714-4339-1, 55714-4339-2 |
Set ID | 0037003f-bc1b-b60e-1b89-e8e5bd55b002 |
Category | OTC ANIMAL DRUG LABEL |
Packager | Newton Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Apis mel. 6x, Echinacea 6x, Apis mel. 15x, Arsenicum alb. 15x, Belladonna 15x, Bromium 15x, Bryonia 15x, Capsicum 15x, Chelidonium majus 15x, Cinchona 15x, Ferrum phos. 15x, Graphites 15x, Lycopodium 15x, Mancinella 15x, Merc. dulc. 15x, Mezereum 15x, Nux vom. 15x, Phos. 15x, Plantago 15x, Pulsatilla 15x, Rhus tox. 15x, Sepia 15x, Verbascum 15x, Viola tric. 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
EAR CARE
apis mel., arsenicum alb., belladonna, bromium, bryonia, capsicum, chelidonium majus, cinchona, ferrum phosphoricum, graphites, lycopodium, mancinella, merc. dulc., mezereum, nux vom., phosphorus, plantago, pulsatilla, rhus toxicodendron, sepia, verbascum, viola tric., echinacea liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-4339 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 15 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X] in 1 mL Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 15 [hp_X] in 1 mL Bromine (UNII: SBV4XY874G) (Bromine - UNII:SBV4XY874G) Bromine 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 Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 15 [hp_X] in 1 mL Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 15 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 15 [hp_X] in 1 mL Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate 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 Hippomane Mancinella Fruiting Leafy Twig (UNII: HU6EYI2I1W) (Hippomane Mancinella Fruiting Leafy Twig - UNII:HU6EYI2I1W) Hippomane Mancinella Fruiting Leafy Twig 15 [hp_X] in 1 mL Calomel (UNII: J2D46N657D) (Calomel - UNII:J2D46N657D) Calomel 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 Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 15 [hp_X] in 1 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 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 Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 15 [hp_X] in 1 mL Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 15 [hp_X] in 1 mL Viola Tricolor (UNII: 9Q24RAI43V) (Viola Tricolor - UNII:9Q24RAI43V) Viola Tricolor 15 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 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:55714-4339-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-4339-2 59.14 mL in 1 BOTTLE, GLASS 3 NDC:55714-4339-0 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 EAR CARE
apis mel., arsenicum alb., belladonna, bromium, bryonia, capsicum, chelidonium majus, cinchona, ferrum phosphoricum, graphites, lycopodium, mancinella, merc. dulc., mezereum, nux vom., phosphorus, plantago, pulsatilla, rhus toxicodendron, sepia, verbascum, viola tric., echinacea liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-4283 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 15 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 15 [hp_X] in 1 mL Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 15 [hp_X] in 1 mL Bromine (UNII: SBV4XY874G) (Bromine - UNII:SBV4XY874G) Bromine 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 Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 15 [hp_X] in 1 mL Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 15 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 15 [hp_X] in 1 mL Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate 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 Hippomane Mancinella Fruiting Leafy Twig (UNII: HU6EYI2I1W) (Hippomane Mancinella Fruiting Leafy Twig - UNII:HU6EYI2I1W) Hippomane Mancinella Fruiting Leafy Twig 15 [hp_X] in 1 mL Calomel (UNII: J2D46N657D) (Calomel - UNII:J2D46N657D) Calomel 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 Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 15 [hp_X] in 1 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 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 Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 15 [hp_X] in 1 mL Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 15 [hp_X] in 1 mL Viola Tricolor (UNII: 9Q24RAI43V) (Viola Tricolor - UNII:9Q24RAI43V) Viola Tricolor 15 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 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:55714-4283-1 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