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

Ear Care by

Drug Labeling and Warnings

Ear Care by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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 liquid

Product 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