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Gel 7 Neutral Topical Fluoride Gel Mint

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 2g in 100g
Labeler: Germiphene Corporation
NDC code: 61508-0176

Medically reviewed by Drugs.com. Last updated on Jan 22, 2024.

Gel 7 Topical Fluoride Gel

Recommended Use:

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.

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.

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.

450 mL (15.2 fl oz)

GEL 7 NEUTRAL TOPICAL FLUORIDE GEL MINT 
fluoride gel gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0176
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM0.3 g  in 100 g
METHYLPARABEN0.08 g  in 100 g
POTASSIUM SORBATE0.1 g  in 100 g
GLYCERIN7 g  in 100 g
SPEARMINT1 g  in 100 g
METHYL SALICYLATE0.1 g  in 100 g
CARBOXYPOLYMETHYLENE1 g  in 100 g
POLYSORBATE 800.1 g  in 100 g
WATER86.9 g  in 100 g
XANTHAN GUM1 g  in 100 g
SODIUM HYDROXIDE0.425 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61508-0176-1450 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/03/2017
GEL 7 NEUTRAL TOPICAL FLUORIDE GEL STRAWBERRY 
fluoride gel gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0179
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM0.3 g  in 100 g
METHYLPARABEN0.08 g  in 100 g
POTASSIUM SORBATE0.1 g  in 100 g
GLYCERIN7 g  in 100 g
STRAWBERRY0.4 g  in 100 g
METHYL SALICYLATE0.1 g  in 100 g
CARBOXYPOLYMETHYLENE1 g  in 100 g
POLYSORBATE 800.1 g  in 100 g
WATER87.5 g  in 100 g
XANTHAN GUM1 g  in 100 g
SODIUM HYDROXIDE0.481 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61508-0179-1450 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/03/2017
Labeler - Germiphene Corporation (206412512)

Document Id: 477fc92b-e607-480f-e054-00144ff8d46c
Set id: 477fc92b-e606-480f-e054-00144ff8d46c
Version: 1
Effective Time: 20170201
 
Germiphene Corporation

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