Label: BESTMADE NATURAL PRODUCTS - MULLEIN EAR DROPS- belladonna, calendula, echinacea, hydrastis, mullein oil, viola odorata liquid

  • NDC Code(s): 82969-6015-1
  • Packager: Bestmade Natural Products
  • 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 December 18, 2024

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  • DOSAGE & ADMINISTRATION

    Apply 4-5 drops into the ear twice daily or as directed by a healthcare provider. (For external use only.)

  • INDICATIONS & USAGE

    Recommended for softening earwax and promoting ear cleanliness as part of maintaining general ear hygiene.

  • INACTIVE INGREDIENT

    Inactive: Alcohol Base to Preserve Remedy

  • ACTIVE INGREDIENT

    Belladonna D10: 0.008mL (HPUS)

    Calendula Ø: 0.010mL (HPUS)

    Echinacea Ø: 0.002mL (HPUS)

    Hydrastis D3: 0.002mL (HPUS)

    Mullein Oil Ø: 0.28mL (HPUS)

    Viola Odorata Ø: 0.002mL (HPUS)

  • KEEP OUT OF REACH OF CHILDREN

    Keep all supplements away from Children.

  • PURPOSE

    Recommended for softening earwax and promoting ear cleanliness as part of maintaining general ear hygiene.

  • WARNINGS

    Warnings:
    Keep all supplements away from Children.
    If you have any reaction to this product that
    is not positive, discontinue use.

  • PRINCIPAL DISPLAY PANEL

    Entire package label

    label

  • INGREDIENTS AND APPEARANCE
    BESTMADE NATURAL PRODUCTS - MULLEIN EAR DROPS 
    belladonna, calendula, echinacea, hydrastis, mullein oil, viola odorata liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82969-6015
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS30 [hp_C]  in 30 [hp_C]
    VIOLA ODORATA WHOLE (UNII: AET12U8B74) (VIOLA ODORATA WHOLE - UNII:AET12U8B74) VIOLA ODORATA WHOLE30 [hp_C]  in 30 [hp_C]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 30 [hp_C]
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP30 [hp_C]  in 30 [hp_C]
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED30 [hp_C]  in 30 [hp_C]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL30 [hp_C]  in 30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 30 [hp_C]  in 30 [hp_C]
    Product Characteristics
    Color    Scoreno score
    ShapeSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82969-6015-130 [hp_C] 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 - Bestmade Natural Products (047124582)
    Establishment
    NameAddressID/FEIBusiness Operations
    Total Operations Management LLC DBA: Bestmade Natural Products Micro047124582manufacture(82969-6015)
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