Label: EAR CARE- influenzinum, tellurium metallicum, apis mel., arsenicum alb., belladonna, bryonia, capsicum, austicum, cinchona, conium,dulcamara, ferrum phosphoricum, hepar sulph. calc.,kali sulph., ycopodium, merc. viv., mezereum,phosphorus, plantago, pulsatilla, silicea,verbascum, echinacea, hydrastis liquid

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated March 1, 2011

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  • 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 - 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%. 

  • 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

  • INGREDIENTS AND APPEARANCE
    EAR CARE  
    influenzinum, tellurium metallicum, apis mel., arsenicum alb., belladonna, bryonia, capsicum, austicum, cinchona, conium,dulcamara, ferrum phosphoricum, hepar sulph. calc.,kali sulph., ycopodium, merc. viv., mezereum,phosphorus, plantago, pulsatilla, silicea,verbascum, echinacea, hydrastis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Influenza A Virus (UNII: R9HH0NDE2E) (Influenza A Virus - UNII:R9HH0NDE2E) Influenza A Virus30 [hp_X]  in 1 mL
    Tellurium (UNII: NQA0O090ZJ) (Tellurium - UNII:NQA0O090ZJ) Tellurium15 [hp_X]  in 1 mL
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera10 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 mL
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna10 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 mL
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum10 [hp_X]  in 1 mL
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum10 [hp_X]  in 1 mL
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
    Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top10 [hp_X]  in 1 mL
    Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top10 [hp_X]  in 1 mL
    Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate10 [hp_X]  in 1 mL
    Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide10 [hp_X]  in 1 mL
    Potassium Sulfate (UNII: 1K573LC5TV) (Sulfate Ion - UNII:7IS9N8KPMG) Potassium Sulfate10 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
    Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury10 [hp_X]  in 1 mL
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark10 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 1 mL
    Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major10 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide10 [hp_X]  in 1 mL
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus10 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 mL
    Influenza B Virus (UNII: 1314JZ2X6W) (Influenza B Virus - UNII:1314JZ2X6W) Influenza B Virus30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-1504-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-1504-259.14 mL in 1 BOTTLE, GLASS
    3NDC:55714-1504-0.5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-1504)
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