EAR CARE - influenza a virus, tellurium, apis mellifera, arsenic trioxide, atropa belladonna, bryonia alba root, capsicum, causticum, cinchona officinalis bark, conium maculatum flowering top, solanum dulcamara stem, ferrosoferric phosphate, calcium sulfide, potassium sulfate, lycopodium clavatum spore, mercury, daphne mezereum bark, phosphorus, plantago major, pulsatilla vulgaris, silicon dioxide, verbascum thapsus, echinacea, unspecified, goldenseal and influenza b virus liquid 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Ear Care

PRODUCT NAME & INDICATIONS SECTION

EAR CARE    Formulated for symptoms associated with Meniere's disease, mastoiditis, otitis, otorrhea and other related ear conditions.   

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops ) one to four times daily or as directed by a healthcare professional. 

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.           

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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

Package Label

EAR CARE  
influenzinum, tellurium metallicum, apis mel, arsenicum alb., belladonna, bryonia, capsicum, causticum, cinchona, conium, dulcamara, ferrum phosphoricum, hepar sulph. calc., kali sulph., lycopodium, merc. viv., mezereum, phosphorus, plantago, pulsatilla, silicea, verbascum, echinacea, hydrastis liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4416
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Influenza A Virus (Influenza A Virus) Influenza A Virus30 [hp_X]  in 1 mL
Tellurium (Tellurium) Tellurium15 [hp_X]  in 1 mL
Apis Mellifera (Apis Mellifera) Apis Mellifera10 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Atropa Belladonna (Atropa Belladonna) Atropa Belladonna10 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root10 [hp_X]  in 1 mL
Capsicum (Capsicum) Capsicum10 [hp_X]  in 1 mL
Causticum (Causticum) Causticum10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (Conium Maculatum Flowering Top) Conium Maculatum Flowering Top10 [hp_X]  in 1 mL
Solanum Dulcamara Stem (Solanum Dulcamara Stem) Solanum Dulcamara Stem10 [hp_X]  in 1 mL
Ferrosoferric Phosphate (Ferrosoferric Phosphate) Ferrosoferric Phosphate10 [hp_X]  in 1 mL
Calcium Sulfide (Calcium Sulfide) Calcium Sulfide10 [hp_X]  in 1 mL
Potassium Sulfate (Sulfate Ion) Potassium Sulfate10 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
Mercury (Mercury) Mercury10 [hp_X]  in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark) Daphne Mezereum Bark10 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus10 [hp_X]  in 1 mL
Plantago Major (Plantago Major) Plantago Major10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Silicon Dioxide (Silicon Dioxide) Silicon Dioxide10 [hp_X]  in 1 mL
Verbascum Thapsus (Verbascum Thapsus) Verbascum Thapsus10 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal3 [hp_X]  in 1 mL
Influenza B Virus (Influenza B Virus) Influenza B Virus30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4416-129.57 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4416), API MANUFACTURE(55714-4416)

Revised: 6/2011
Document Id: 0b2f1a75-e18f-da75-f180-d37545d1131c
Set id: e7c5d1e7-8f0b-bb84-9e95-d41af27bdf52
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.