Inactive Ingredient
Ethanol 35%, Distilled water, Glycerin, Methyl paraben, Propyl paraben
Bm Natural Mullein Ear Solution/ Drops
FDA Label NDC 85816-6015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bm Private Limited for the product Bm Natural Mullein Ear (NDC 85816-6015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredient, otc - active ingredient, indications & usage, otc - purpose, dosage & administration, contraindications, warnings, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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).
Otc - 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.
Otc - 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.
Package Label.Principal Display Panel
Entire package label
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