Label: CHILDRENS EARACHE RELIEF- aconitum napellus, allium capa, apis mellifica, belladonna, calcarea carbonica, capsicum annuum, causticum, chamomilla, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali muriaticum, mercurius dulcis, mercurius solubilis, plantago major, and silicea liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 April 13, 2012

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  • Active Ingredients

    Official HPUS: Aconitum napellus, Allium capa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, and Silicea.

    Reference image childrens earache.jpg

  • Inactive Ingredient

    Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

    Reference image childrens earache.jpg

  • Dosage and Administration

    Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed.

    Adult Dose 3 pump sprays

    Children 2-12 years 2 pump sprays

    Reference image childrens earache.jpg

  • Purpose

    Uses for fast relief of earache symptoms:

    • ear pain
    • inflammation
    • discharge
    • fever
    • congestion
    • sensitivity to noise
    • ringing
    • throbbing
    • buzzing
    • humming
    Reference image childrens earache.jpg

  • Warnings

    If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

    Other: Tamper resistant for your protection. Use only if safety seal is intact.

    Reference image childrens earache.jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Reference image childrens earache.jpg

  • Indications and Usage

    Uses for fast relief of earache symptoms: ear pain, inflammation, discharge, fever, congestion, sensitivity to noise, ringing, throbbing, buzzing, and humming.

    Reference image childrens earache.jpg

  • PRINCIPAL DISPLAY PANEL

    Image of label


    King Bio Inc.

    3 Westside Drive

    Asheville, NC 28806

    Questions? Call 800.543.3245

    www.kingbio.com

  • INGREDIENTS AND APPEARANCE
    CHILDRENS EARACHE RELIEF 
    aconitum napellus, allium capa, apis mellifica, belladonna, calcarea carbonica, capsicum annuum, causticum, chamomilla, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali muriaticum, mercurius dulcis, mercurius solubilis, plantago major, and silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 59 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION10 [hp_X]  in 59 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 59 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]  in 59 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM10 [hp_X]  in 59 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP10 [hp_X]  in 59 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERRIC CATION - UNII:91O4LML611) FERROSOFERRIC PHOSPHATE10 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE10 [hp_X]  in 59 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE10 [hp_X]  in 59 mL
    CALOMEL (UNII: J2D46N657D) (CALOMEL - UNII:J2D46N657D) CALOMEL10 [hp_X]  in 59 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS10 [hp_X]  in 59 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR10 [hp_X]  in 59 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5315-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2011
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture
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