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.
A topical anticaries preparation for professional dental use only.
Gel 7 contains 2.0% sodium fluoride to supply 1.0% fluoride ion in a thixotropic gel base at pH 7.
1.0 % Fluoride ion
Purified water, glycerin, potassium sorbate, methyl paraben, polysorbate 80, sodium saccharin, methyl salcylate, acrylic polymer, sodium hydroxide, xanthan gum, and flavouring agents.
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.
Keep out of reach of children.
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.
450 mL (15.2 fl oz)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61508-0176-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8ec0-f424-e053-dadaa90a57ce | Gel 7 Topical Fluoride Gel |
| 61508-0179-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8ec0-f424-e053-dadaa90a57ce | Gel 7 Topical Fluoride Gel |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61508-0176-1 | Gel 7 Neutral Topical Fluoride Gel Mint | 450 g in 1 BOTTLE, PLASTIC | GEL, DENTIFRICE | 450 | 1 | |
| 61508-0179-1 | Gel 7 Neutral Topical Fluoride Gel Strawberry | 450 g in 1 BOTTLE, PLASTIC | GEL, DENTIFRICE | 450 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61508-0176 | GEL 7 NEUTRAL TOPICAL FLUORIDE GEL MINT (FLUORIDE GEL) GEL, DENTIFRICE GEL 7 NEUTRAL TOPICAL FLUORIDE GEL STRAWBERRY (FLUORIDE GEL) GEL, DENTIFRICE [GERMIPHENE CORPORATION] | 1 | Legacy NDC, 1 package rows | 20170203_477fc92b-e606-480f-e054-00144ff8d46c.zip |
| 61508-0179 | GEL 7 NEUTRAL TOPICAL FLUORIDE GEL MINT (FLUORIDE GEL) GEL, DENTIFRICE GEL 7 NEUTRAL TOPICAL FLUORIDE GEL STRAWBERRY (FLUORIDE GEL) GEL, DENTIFRICE [GERMIPHENE CORPORATION] | 1 | Legacy NDC, 1 package rows | 20170203_477fc92b-e606-480f-e054-00144ff8d46c.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61508-0176 | 61508-0176-1 |
| 61508-0179 | 61508-0179-1 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 477fc92b-e607-480f-e054-00144ff8d46c | 477fc92b-e606-480f-e054-00144ff8d46c | 2017-02-01 | Warnings | 477fc92b-e607-480f-e054-00144ff8d46c 477fc92b-e606-480f-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.