| NDC | 61508-0163-1, 61508-0165-1, 61508-0166-1, 61508-0167-1, 61508-0169-1 |
| Set ID | 487f6aa0-be7d-39f8-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Germiphene Corporation |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- 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)
