Label: EAR INFLAMMATION PLUS (belladonna, conium maculatum, dulcamara, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla- vulgaris, 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 May 13, 2014

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

View All Sections
  • ACTIVE INGREDIENTS:

    Belladonna 30X, Conium maculatum 30X, Dulcamara 30X, Hepar sulphuris calcareum 30X, Kali bichromicum 30X, Mercurius solubilis 30X, Pulsatilla (Vulgaris) 30X, Silicea 30X, Chamomilla 30C.

  • INDICAITONS:

    For temporary relief of symptoms due to inflammation and pain of the ears.

  • WARNINGS:

    Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding, ask a health professional before use.

    Do not use if tamper evident seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN: 

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of symptoms due to inflammation and pain of the ears.

  • INACTIVE INGREDIENTS: 

     Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    SYNERGY FORMULAS, iNC.

    251 West Road

    Campobello, SC 29322

  • PACKAGE LABEL DISPLAY: 

    Synergy Formulas

    EAR INFLAMMATION PLUS

    HOMEOPATHIC

    2 FL OZ (60 ML)

    Ear Inflammation Plus

  • INGREDIENTS AND APPEARANCE
    EAR INFLAMMATION PLUS 
    belladonna, conium maculatum, dulcamara, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (vulgaris), liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]  in 1 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP30 [hp_X]  in 1 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP30 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_X]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS30 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0032-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/13/2014
    Labeler - Synergy Formulas, Inc. (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0032) , api manufacture(43772-0032) , label(43772-0032) , pack(43772-0032)
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!