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Ear Wax Build-Up (Newton Laboratories, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID .5 mL in 1 BOTTLE, GLASS (55714-2332-0) Label Information
LIQUID 59.14 mL in 1 BOTTLE, GLASS (55714-2332-2) Label Information
LIQUID 29.57 mL in 1 BOTTLE, GLASS (55714-2332-1) Label Information

Complete Ear Wax Build-Up Information

  • INDICATIONS & USAGE SECTION

    Ear Wax Build-Up    Formulated for associated symptoms such as ear discharge, dryness, itching, hearing difficulties and excess wax accumulation.


  • DOSAGE & ADMINISTRATION SECTION

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


  • OTC - ACTIVE INGREDIENT SECTION

    Elaps corallinus 30x, Alumina 10x, Carbo veg. 10x, Causticum 10x, Conium 10x, Graphites 10x, Kali bic. 10x, Kali mur. 10x, Lachesis 10x, Lycopodium 10x, Petroleum 10x,Pulsatilla 10x, Sabadilla 10x, Sepia 10x, Silicea 10x, Spongia 10x, Verbascum 10x, Viola odorata 10x.


  • OTC - PURPOSE SECTION

     Formulated for associated symptoms such as ear discharge, dryness, itching, hearing difficulties and excess wax accumulation.


  • 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 WAX BUILD-UP  
    elaps corallinus, alumina, carbo veg., causticum, conium, graphites, kali bic.,kali mur., lachesis, lycopodium, petroleum, pulsatilla, sabadilla, sepia, silicea, spongia, verbascum, viola odorata liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2332
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Micrurus Corallinus Venom (UNII: V0S6H36980) (Micrurus Corallinus Venom - UNII:V0S6H36980) Micrurus Corallinus Venom 30 [hp_X]  in 1 mL
    Aluminum Oxide (UNII: LMI26O6933) (Aluminum Oxide - UNII:LMI26O6933) Aluminum Oxide 10 [hp_X]  in 1 mL
    Activated Charcoal (UNII: 2P3VWU3H10) (Activated Charcoal - UNII:2P3VWU3H10) Activated Charcoal 10 [hp_X]  in 1 mL
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum 10 [hp_X]  in 1 mL
    Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top 10 [hp_X]  in 1 mL
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite 10 [hp_X]  in 1 mL
    Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate 10 [hp_X]  in 1 mL
    Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152) Potassium Chloride 10 [hp_X]  in 1 mL
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 10 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [hp_X]  in 1 mL
    Liquid Petroleum (UNII: 6ZAE7X688J) (Liquid Petroleum - UNII:6ZAE7X688J) Liquid Petroleum 10 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 10 [hp_X]  in 1 mL
    Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon Officinale Seed 10 [hp_X]  in 1 mL
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 10 [hp_X]  in 1 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 10 [hp_X]  in 1 mL
    Spongia Officinalis Skeleton, Roasted (UNII: 1PIP394IID) (Spongia Officinalis Skeleton, Roasted - UNII:1PIP394IID) Spongia Officinalis Skeleton, Roasted 10 [hp_X]  in 1 mL
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 10 [hp_X]  in 1 mL
    Viola Odorata (UNII: AET12U8B74) (Viola Odorata - UNII:AET12U8B74) Viola Odorata 10 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55714-2332-1 29.57 mL in 1 BOTTLE, GLASS
    2 NDC:55714-2332-2 59.14 mL in 1 BOTTLE, GLASS
    3 NDC:55714-2332-0 .5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    Name Address ID/FEI Business Operations
    Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2332) , API MANUFACTURE(55714-2332)