GEL 7 NEUTRAL TOPICAL FLUORIDE GEL MINT- fluoride gel gel, dentifrice 
GEL 7 NEUTRAL TOPICAL FLUORIDE GEL STRAWBERRY- fluoride gel gel, dentifrice 
Germiphene Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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.

Gel 7 Strawberry Label

450 mL (15.2 fl oz)

Mint Label

GEL 7 NEUTRAL TOPICAL FLUORIDE GEL MINT 
fluoride gel gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0176
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.3 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.08 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 7 g  in 100 g
SPEARMINT (UNII: J7I2T6IV1N) 1 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) 0.1 g  in 100 g
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 1 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
WATER (UNII: 059QF0KO0R) 86.9 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 1 g  in 100 g
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.425 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0176-1450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2017
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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.3 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.08 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 7 g  in 100 g
STRAWBERRY (UNII: 4J2TY8Y81V) 0.4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) 0.1 g  in 100 g
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 1 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
WATER (UNII: 059QF0KO0R) 87.5 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 1 g  in 100 g
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.481 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0179-1450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/03/2017
Labeler - Germiphene Corporation (206412512)

Revised: 2/2017
Document Id: 477fc92b-e607-480f-e054-00144ff8d46c
Set id: 477fc92b-e606-480f-e054-00144ff8d46c
Version: 1
Effective Time: 20170201
 
Germiphene Corporation