Label: 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
-
Contains inactivated NDC Code(s)
NDC Code(s): 61508-0163-1, 61508-0165-1, 61508-0166-1, 61508-0167-1, view more61508-0169-1 - Packager: Germiphene Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated February 14, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Recommended use or purpose:
- PURPOSE
- Medicinal Ingredient:
- Non-medicinal ingredients:
- Directions:
- KEEP OUT OF REACH OF CHILDREN
- Warning/Caution:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
60 SECOND GEL BUBBLEGUM
fluoride gel gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61508-0163 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.69 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61508-0163-1 450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/24/2017 60 SECOND GEL STRAWBERRY
fluoride gel gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61508-0169 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.69 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61508-0169-1 450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/24/2017 60 SECOND GEL GRAPE
fluoride gel gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61508-0165 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.69 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61508-0165-1 450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/24/2017 60 SECOND GEL MINT
fluoride gel gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61508-0166 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.69 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61508-0166-1 450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/24/2017 60 SECOND GEL ORANGE CREAM
fluoride gel gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61508-0167 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.69 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61508-0167-1 450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/24/2017 Labeler - Germiphene Corporation (206412512)
