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 
Newton Laboratories, Inc.

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.

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Ear Care

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

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

Revised: 1/2019
Document Id: 15e46d93-7f99-4888-8ed5-490622d41d62
Set id: 0037003f-bc1b-b60e-1b89-e8e5bd55b002
Version: 3
Effective Time: 20190114
 
Newton Laboratories, Inc.