Recommended Use Or Purpose:
A topical APF anticaries preparation for dental use only.
60 Second Gel Orange Cream
FDA Label NDC 61508-0167
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 60 Second Gel Orange Cream (NDC 61508-0167). 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 or purpose:, otc - purpose, medicinal ingredient:, non-medicinal ingredients:, directions:, otc - keep out of reach of children, warning/caution:, 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
1.23% fluoride ion from sodium fluoride and hydrofluoric acid. Optimized low pH for a complete fluoride treatment in 60 seconds.
Medicinal Ingredient:
1.23% fluoride ion
Non-Medicinal Ingredients:
Water, glycerin, sodium saccharin, methyl paraben, potassium sorbate, phosphoric acid, hydrofluoric acid, acrylic polymer, silicon dioxide, zanthan gum, polysorbate 80 & flavoring agents.
Directions:
Shake well before using. Fill Germiphene brand disposable trays to appropriate level. After prophylaxis, air dry teeth and insert trays for one minute. Remove trays and have patient expectorate excess gel.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Warning/Caution:
Do not eat, drink, or rinse for 30 minutes after treatment. Do not use if tamper-evident seal is broken. Do not store in direct sunlight.
* Please review the disclaimer below.
