Recommended Use:
Oro Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.
Oromin
FDA Label NDC 61508-0200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Germiphene Corporation for the product Oromin (NDC 61508-0200). 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 recommended use:, otc - purpose, medicinal ingredient:, non-medicinal ingredients:, directions:, 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
Otc - Purpose
ORO Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.
Medicinal Ingredient:
Calcium chloride 0.054%, sodium fluoride 0.02%, sodium phosphate 0.056%
Non-Medicinal Ingredients:
Water, ethyl alcohol, sorbitol solution, sodium chloride, edetate disodium, sodium benzoate, polysorbate 20, polysorbate 80, methyl paraben, sodium saccharin, propyl paraben, and flavouring agent.
Directions:
After brushing and flossing, rinse 10-15 mL of ORO Min (fill cap 3/4 full) between teeth for 60 seconds, then spit out. Do not swallow. Do not eat or drink for 30 minutes after rinsing. Use twice a day or as directed by your dentist or hygienist.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Warnings
Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.
Package Label.Principal Display Panel
500 mL (61508 0200 1)
50 mL (61508 0200 2)
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