The following Structured Product Label (SPL) was submitted to the FDA by Elevate Oral Care for the product Fluorimax 5000 Sensitive (NDC 57511-0503). 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 warnings, package label and instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
WARNINGS: Do not swallow. Keep out of reach of children under 12 yeaars of age. Read all instructions and prescribing information before using this product. Don't freeze or expose to extreme heat.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
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