Active Ingredients And Purpose
OTC - PURPOSE SECTION
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
Gel 7 Neutral Topical Fluoride Gel Strawberry
- Manufacturer
- Germiphene Corporation
- Effective date
- 2017-02-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:48:42
Key Label Information#
Uses
Recommended Use:
A topical anticaries preparation for professional dental use only.
Warnings
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.
Directions And Dosage
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.
Other Label Information
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
450 mL (15.2 fl oz)
Label Images#
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| 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 |
DailyMed Package Descriptions#
| 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 |
DailyMed Dashboard NDC Coverage#
| 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 |
Products#
- Gel 7 Neutral Topical Fluoride Gel Mint
- Fluoride Gel
- FLUORIDE ION
- Gel 7 Neutral Topical Fluoride Gel Strawberry
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61508-0176 | 61508-0176-1 |
| 61508-0179 | 61508-0179-1 |
Ingredients#
Complete SPL Sections#
Recommended Use:
A topical anticaries preparation for professional dental use only.
OTC - PURPOSE SECTION
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 SECTION
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
450 mL (15.2 fl oz)