Label: CHILDRENS EAR RELIEF- aconitum napellus, allium cepa, apis mellifica, belladonna, calcarea carbonica, capsicum annuum, causticum, chamomilla, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali muriaticum, mercurius dulcis, mercurius solubilis, plantago major, 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 March 31, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________________

    HPUS active ingredients: Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

  • INDICATIONS & USAGE

    Uses  NOTE: Do not use in ear. Oral spray only. For temporary relief of symptoms: clogged sensation, noises in ear, accumulation of ear wax.

  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically Enhanced pure water, citric acid, potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults 12 and up 3 sprays 3 times per day.
    • Children 2-12- 2 sprays 3 times per day.
    • Children 2 mo.-2yr.- 1 spray 3 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been independently tested.

  • PURPOSE

    Uses NOTE: Do not use in ear. Oral spray only. For temporary relief of symptoms:

    • clogged sensation
    • noises in ear
    • accumulation of ear wax
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CHILDRENS EAR RELIEF 
    aconitum napellus, allium cepa, apis mellifica, belladonna, calcarea carbonica, capsicum annuum, causticum, chamomilla, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali muriaticum, mercurius dulcis, mercurius solubilis, plantago major, silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0758
    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, CRUDE10 [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) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE10 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) 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) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0758-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/31/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0758)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!