EAR CARE (APIS MEL., ARSENICUM ALB., BELLADONNA, BROMIUM, BRYONIA, CAPSICUM, CHELIDONIUM MAJUS, CINCHONA, FERRUM PHOSPHORICUM, GRAPHITES, LYCOPODIUM, MANCINELLA, MERC. DULC., MEZEREUM, NUX VO

EAR CARE (APIS MEL., ARSENICUM ALB., BELLADONNA, BROMIUM, BRYONIA, CAPSICUM, CHELIDONIUM MAJUS, CINCHONA, FERRUM PHOSPHORICUM, GRAPHITES, LYCOPODIUM, MANCINELLA, MERC. DULC., MEZEREUM, NUX VO
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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

    Formulated for associated symptoms such as discomfort, itching, irritation, inflammation and swelling.

  • 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) one to four times daily or as directed by a health professional. Place in mouth or purified water. 

  • 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

    Formulated for associated symptoms such as discomfort, itching, irritation, inflammation and swelling.

  • INACTIVE INGREDIENT SECTION

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

  • QUESTIONS SECTION

    newtonlabs.net  Questions?  1.800.448.7256  
    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. 

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label
    package label

  • 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 liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-4339
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 mL
    Bromine (UNII: SBV4XY874G) (Bromine - UNII:SBV4XY874G) Bromine15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum15 [hp_X]  in 1 mL
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mL
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
    Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate15 [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
    Hippomane Mancinella Fruiting Leafy Twig (UNII: HU6EYI2I1W) (Hippomane Mancinella Fruiting Leafy Twig - UNII:HU6EYI2I1W) Hippomane Mancinella Fruiting Leafy Twig15 [hp_X]  in 1 mL
    Calomel (UNII: J2D46N657D) (Calomel - UNII:J2D46N657D) Calomel15 [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
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
    Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major15 [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
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mL
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus15 [hp_X]  in 1 mL
    Viola Tricolor (UNII: 9Q24RAI43V) (Viola Tricolor - UNII:9Q24RAI43V) Viola Tricolor15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4339-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-4339-259.14 mL in 1 BOTTLE, GLASS
    3NDC:55714-4339-014.78 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/15/201112/31/2018
    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 liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-4283
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 mL
    Bromine (UNII: SBV4XY874G) (Bromine - UNII:SBV4XY874G) Bromine15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum15 [hp_X]  in 1 mL
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mL
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
    Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate15 [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
    Hippomane Mancinella Fruiting Leafy Twig (UNII: HU6EYI2I1W) (Hippomane Mancinella Fruiting Leafy Twig - UNII:HU6EYI2I1W) Hippomane Mancinella Fruiting Leafy Twig15 [hp_X]  in 1 mL
    Calomel (UNII: J2D46N657D) (Calomel - UNII:J2D46N657D) Calomel15 [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
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
    Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major15 [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
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mL
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus15 [hp_X]  in 1 mL
    Viola Tricolor (UNII: 9Q24RAI43V) (Viola Tricolor - UNII:9Q24RAI43V) Viola Tricolor15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4283-130 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/14/2019
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture, api manufacture

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