Label: BM NATURAL MULLEIN EAR- belladonna, calendula, echinacea, hydrastis, mullein oil, viola odorata solution/ drops

  • 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 June 27, 2025

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  • INACTIVE INGREDIENT

    Ethanol 35%, Distilled water, Glycerin, Methyl paraben, Propyl paraben

  • ACTIVE INGREDIENT

    Active ingredients (Ref. stand.) Each mL contains Belladonna D10 0.008mL (HPUS) Calendula ∅ 0.010mL (HPUS) Echinacea ∅ 0.002mL (HPUS) Hydrastis D3 0.002mL (HPUS) Mullein oil ∅ 0.28mL (HPUS) Viola odorata ∅ 0.002mL (HPUS)

  • INDICATIONS & USAGE

    Indications: Help support to relieve the symptoms of otalgia and otorrhoea, for detail please read the enclosed package (Product information leaflet).

  • PURPOSE

    Indications: Help support to relieve the symptoms of otalgia and otorrhoea, for detail please read the enclosed package (Product information leaflet).

  • DOSAGE & ADMINISTRATION

    How to use: Instill 4-5 drops twice a day.

  • CONTRAINDICATIONS

    Care & contra-indications: This is a homeopathic product, no contra-indications are established.

  • WARNINGS

    Precautions/storage: Keep away from children and store at cool and dry place.

  • KEEP OUT OF REACH OF CHILDREN

    Precautions/storage: Keep away from children and store at cool and dry place.

  • STORAGE AND HANDLING

    Precautions/storage: Keep away from children and store at cool and dry place.

  • PRINCIPAL DISPLAY PANEL

    Entire package label

    mullein

  • INGREDIENTS AND APPEARANCE
    BM NATURAL MULLEIN EAR 
    belladonna, calendula, echinacea, hydrastis, mullein oil, viola odorata solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85816-6015
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA1 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS1 [hp_X]  in 1 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED1 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.6 mg  in 1 mL
    METHYLPARABEN (UNII: A2I8C7HI9T) 1 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.27 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.38 mL  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) 0.35 mL  in 1 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85816-6015-115 mL in 1 BOTTLE, DROPPER; Type 6: Drug/Biologic Combination01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2015
    Labeler - BM Private Limited (645599762)
    Establishment
    NameAddressID/FEIBusiness Operations
    BM Private Limited645599762manufacture(85816-6015)
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