60 SECOND GEL BUBBLEGUM- fluoride gel gel, dentifrice 
60 SECOND GEL STRAWBERRY- fluoride gel gel, dentifrice 
60 SECOND GEL GRAPE- fluoride gel gel, dentifrice 
60 SECOND GEL MINT- fluoride gel gel, dentifrice 
60 SECOND GEL ORANGE CREAM- 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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60 Second Gel

Recommended use or purpose:

A topical APF anticaries preparation for dental use only.

1.23% fluoride ion from sodium fluoride and hydrofluoric acid. Optimized low pH for a complete fluoride treatment in 60 seconds.

Medicinal Ingredient:

1.23% fluoride ion

Non-medicinal ingredients:

Water, glycerin, sodium saccharin, methyl paraben, potassium sorbate, phosphoric acid, hydrofluoric acid, acrylic polymer, silicon dioxide, zanthan gum, polysorbate 80 & flavoring agents.

Directions:

Shake well before using. Fill Germiphene brand disposable trays to appropriate level. After prophylaxis, air dry teeth and insert trays for one minute. 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. Do not use if tamper-evident seal is broken. Do not store in direct sunlight.

60 Second Gel Orange Cream60 Second Gel Mint60 Second Gel Grape60 Second Gel Bubblegum60 Second Gel Strawberry

60 SECOND GEL BUBBLEGUM 
fluoride gel gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0163
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.69 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.55 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.08 g  in 100 g
WATER (UNII: 059QF0KO0R) 84.365 g  in 100 g
PHOSPHORIC ACID (UNII: E4GA8884NN) 0.933 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 7 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g  in 100 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 1 g  in 100 g
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 1 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.2 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 1 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0163-1450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/24/2017
60 SECOND GEL STRAWBERRY 
fluoride gel gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0169
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.69 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.55 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.08 g  in 100 g
WATER (UNII: 059QF0KO0R) 85.965 g  in 100 g
PHOSPHORIC ACID (UNII: E4GA8884NN) 0.933 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 7 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g  in 100 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 1 g  in 100 g
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 1 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.2 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 1 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0169-1450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/24/2017
60 SECOND GEL GRAPE 
fluoride gel gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0165
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.69 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.55 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.08 g  in 100 g
WATER (UNII: 059QF0KO0R) 86.265 g  in 100 g
PHOSPHORIC ACID (UNII: E4GA8884NN) 0.933 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 7 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g  in 100 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 1 g  in 100 g
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 1 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.2 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 1 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0165-1450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/24/2017
60 SECOND GEL MINT 
fluoride gel gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0166
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.69 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.549 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.08 g  in 100 g
WATER (UNII: 059QF0KO0R) 85.065 g  in 100 g
PHOSPHORIC ACID (UNII: E4GA8884NN) 0.933 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 7 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g  in 100 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 0.999 g  in 100 g
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.999 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.2 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 0.999 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) 0.3 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0166-1450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/24/2017
60 SECOND GEL ORANGE CREAM 
fluoride gel gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0167
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.69 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.549 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.08 g  in 100 g
WATER (UNII: 059QF0KO0R) 847.665 g  in 100 g
PHOSPHORIC ACID (UNII: E4GA8884NN) 0.933 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 7 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g  in 100 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 0.999 g  in 100 g
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.999 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.2 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 0.999 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0167-1450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/24/2017
Labeler - Germiphene Corporation (206412512)

Revised: 2/2017
Document Id: 487f6aa0-be7e-39f8-e054-00144ff88e88
Set id: 487f6aa0-be7d-39f8-e054-00144ff88e88
Version: 1
Effective Time: 20170214
 
Germiphene Corporation