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

BM Natural Mullein Ear by

Drug Labeling and Warnings

BM Natural Mullein Ear by is a Homeopathic medication manufactured, distributed, or labeled by BM Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85816-6015
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74)	VIOLA ODORATA	1 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	10 [hp_X]  in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	1 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	1 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85816-6015-1	15 mL in 1 BOTTLE, DROPPER; Type 6: Drug/Biologic Combination	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2015

Labeler - BM Private Limited (645599762)

Establishment
Name	Address	ID/FEI	Business Operations
BM Private Limited		645599762	manufacture(85816-6015)