Inactive Ingredient
Lactose, Magnesium Stearate
Bm Tooth Remineralization Globule
FDA Label NDC 82969-6110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Total Operations Management Llc Dba:bestmade Natural Products Micro for the product Bm Tooth Remineralization (NDC 82969-6110). 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, health claim, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses*
Helps temporarily relieve: tooth sensitivity to hot or cold; discomfort associated with weakened or worn tooth enamel.
Otc - Purpose
Calc Phos 12X.......weak enamel, tooth sensitivity
Calc Fluor 12X....... weak enamel, tissue weakness
Silicea 12X.............. gum weakness, tooth sensitivity
Dosage & Administration
Use as directed.
Take with water, 3-4 times daily. Ages 12 and older: 5 pellets. Ages 3 to 11: 3 pellets. Ages below 3: consult your doctor.
Otc - Active Ingredient
Calc Phos 12X, Calc Fluor 12X, Silicea 12X
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Stop use and ask a doctor if symptoms persist or worsen.
If you have severe symptoms, consult a doctor before use.
Warnings
Keep out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Stop use and ask a doctor if symptoms persist or worsen.
If you have severe symptoms, consult a doctor before use.
Health Claim
*Claims based on Traditional Homeopathic Practice, Not Accepted Medical Evidence, Not FDA Evaluated.
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* Please review the disclaimer below.
