Ear Care description, usages, side effects, indications, overdosage, supplying and lots more!

Ear Care

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Ear Care

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Ear Care       Formulated for symptoms associated with ear conditions such as discomfort, itching, irritation, inflammation, swelling and foul discharge.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.    Pets, under 50 lbs., give 3 drops orally (50 to 500 lbs. - 6 drops, over 500 lbs. - 1/2 teaspoon) one to four times daily or as directed by a healthcare professional. Place in mouth or purified water.

OTC - ACTIVE INGREDIENT SECTION

Apis mel. 15x, Arsenicum alb. 15x, Belladonna 15x, Bromium 15x, Bryonia 15x, Capsicum 15x, Chelidonium majus 15x, Cinchona 15x, Ferrum phosphoricum 15x, Graphites 15x, Lycopodium 15x, Mancinella 15x, Merc. dulc. 15x, Mezereum 15x, Nux vom. 15x, Phosphorus 15x, Plantago 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sepia 15x, Verbascum 15x, Viola tric. 15x, Apis mel. 3x Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with ear conditions such as discomfort, itching, irritation, inflammation, swelling and foul discharge.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 Type Otc animal drug label Item Code (Source) NDC:55714-4339
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
APIS MELLIFERA APIS MELLIFERA 15 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 15 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 15 [hp_X]
BROMINE BROMINE 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
Capsicum CAPSICUM 15 [hp_X]
CHELIDONIUM MAJUS CHELIDONIUM MAJUS 15 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 15 [hp_X]
FERROSOFERRIC PHOSPHATE Ferrosoferric Phosphate 15 [hp_X]
Graphite GRAPHITE 15 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 15 [hp_X]
Hippomane Mancinella Fruiting Leafy Twig HIPPOMANE MANCINELLA FRUITING LEAFY TWIG 15 [hp_X]
Calomel CALOMEL 15 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 15 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 15 [hp_X]
PHOSPHORUS PHOSPHORUS 15 [hp_X]
PLANTAGO MAJOR PLANTAGO MAJOR 15 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 15 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 15 [hp_X]
SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE 15 [hp_X]
VERBASCUM THAPSUS VERBASCUM THAPSUS 15 [hp_X]
VIOLA TRICOLOR 15 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4339-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-4339-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-4339-0 .5 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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