Recommended Use:
A topical anticaries preparation for professional dental use only.
Gel 7 Neutral Topical Fluoride Gel Strawberry
FDA Label NDC 61508-0179
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 Gel 7 Neutral Topical Fluoride Gel Strawberry (NDC 61508-0179). 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, 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
Gel 7 contains 2.0% sodium fluoride to supply 1.0% fluoride ion in a thixotropic gel base at pH 7.
Medicinal Ingredient:
1.0 % Fluoride ion
Non-Medicinal Ingredients:
Purified water, glycerin, potassium sorbate, methyl paraben, polysorbate 80, sodium saccharin, methyl salcylate, acrylic polymer, sodium hydroxide, xanthan gum, and flavouring agents.
Directions:
1. Shake well before using. 2. Fill Germiphene brand disposable gel trays to appropriate level. 3. After thorough prophylaxis, air dry teeth and insert trays for four minutes. 4. 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. Shake bottle vigorously before dispensing. Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.
Package Label.Principal Display Panel
Gel 7 Strawberry Label (G7 St 450)
450 mL (15.2 fl oz)
Mint Label (G7 Mt 450)
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