Inactive Ingredient
Lactose, Magnesium Stearate
Bm Tooth Remineralization Globule
FDA Label NDC 85816-6010
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 Tooth Remineralization (NDC 85816-6010). 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, indications & usage, otc - purpose, dosage & administration, otc - active ingredient, otc - keep out of reach of children, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Indications:
See the leaflet enclosed for detail.
Otc - Purpose
Indications:
See the leaflet enclosed for detail.
Dosage & Administration
Dosage:
Adult: Four tablets three times a day,
Children: half of the same or as advised by a homoeopathic physician.
Otc - Active Ingredient
Calc Fluor, Silicea, Calc P 12X
Otc - Keep Out Of Reach Of Children
Precautions/storage:
Keep away from children and store at cool and dry place.
Warnings
Precautions/storage:
Keep away from children and store at cool and dry place.
Package Label.Principal Display Panel
Package 1:
Package 2:
* Please review the disclaimer below.
