Label: GEL 7 NEUTRAL TOPICAL FLUORIDE GEL MINT- fluoride gel gel, dentifrice
GEL 7 NEUTRAL TOPICAL FLUORIDE GEL STRAWBERRY- fluoride gel gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 61508-0176-1, 61508-0179-1 - 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 1, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Recommended Use:
- PURPOSE
- Medicinal Ingredient:
- Non-medicinal ingredients:
- Directions:
- KEEP OUT OF REACH OF CHILDREN
- Warning/Caution:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GEL 7 NEUTRAL TOPICAL FLUORIDE GEL MINT
fluoride gel gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61508-0176 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61508-0176-1 450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/03/2017 GEL 7 NEUTRAL TOPICAL FLUORIDE GEL STRAWBERRY
fluoride gel gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61508-0179 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61508-0179-1 450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/03/2017 Labeler - Germiphene Corporation (206412512)
