Ear Care

Ear Care
SPL v1
SPL
SPL Set ID e28c6dc2-ee5b-1fe5-0f91-085106371387
Route
ORAL
Published
Effective Date 2012-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Influenza A Virus (30 [hp_X]) Tellurium (15 [hp_X]) Apis Mellifera (10 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Atropa Belladonna Bryonia Alba Root Capsicum Causticum Cinchona Officinalis Bark Conium Maculatum Flowering Top Solanum Dulcamara Top Ferrosoferric Phosphate Calcium Sulfide Sulfate Ion Lycopodium Clavatum Spore Mercury Daphne Mezereum Bark Phosphorus Plantago Major Pulsatilla Vulgaris Silicon Dioxide Verbascum Thapsus Echinacea, Unspecified Goldenseal Influenza B Virus
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Ear Care  Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Purpose

Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.


Medication Information

Purpose

Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Description

Ear Care  Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Package Label

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.  

Questions Section

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

Questions?  1.800.448.7256

Otc Purpose Section

Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Inactive Ingredient Section

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

Indications & Usage Section

Ear Care  Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL. Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Influenzinum 30x, Tellurium metallicum 15x, Apis mel. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Capsicum 10x, Causticum 10x, Cinchona 10x, Conium 10x, Dulcamara 10x, Ferrum phosphoricum 10x, Hepar sulph. calc. 10x, Kali sulph. 10x, Lycopodium 10x, Merc. viv. 10x, Mezereum 10x, Phosphorus 10x, Plantago 10x, Pulsatilla 10x, Silicea 10x, Verbascum 10x, Echinacea 3x, Hydrastis 3x.

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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.  

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Ear Care  Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY - SHAKE WELL. Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Influenzinum 30x, Tellurium metallicum 15x, Apis mel. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Capsicum 10x, Causticum 10x, Cinchona 10x, Conium 10x, Dulcamara 10x, Ferrum phosphoricum 10x, Hepar sulph. calc. 10x, Kali sulph. 10x, Lycopodium 10x, Merc. viv. 10x, Mezereum 10x, Phosphorus 10x, Plantago 10x, Pulsatilla 10x, Silicea 10x, Verbascum 10x, Echinacea 3x, Hydrastis 3x.

Otc Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)