Label: GEL 1100 MINT- sodium fluoride gel, dentifrice
GEL 1100 CITRUS- sodium fluoride gel, dentifrice
GEL 1100 GRAPE- sodium fluoride gel, dentifrice

  • NDC Code(s): 61578-213-01, 61578-214-01, 61578-217-01
  • Packager: Dental Alliance Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • Active ingredients:

    Sodium Fluoride 0.24%

  • Purpose:

    Anticavity

  • Use:

    Aids in the prevention of dental caries (cavities)

  • Warnings:

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Warnings:

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

  • Inactive ingredients:

    Glycerin, Hydrated Silica, Hydrogenated Starch Hydrolysate (HSH), Hydroxyapatite, Hydroxyethyl Cellulose, Menthol (Mint only), Natural Flavors, Artificial Flavors (Citrus and Grape only) Polysorbate 20, Potassium Sorbate, Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water, Xylitol

  • Gel 1100 Mint, Citrus, and Grape enclosure and carton labels

    Box Principle Display PanelBox Principle Display PanelBox Principle Display PanelTube Principle Display PanelTube Principle Display PanelTube Principle Display Panel

  • INGREDIENTS AND APPEARANCE
    GEL 1100  MINT
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-213
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1100 ug  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MALTITOL (UNII: D65DG142WK)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN (UNII: FST467XS7D)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61578-213-0168 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/10/2022
    GEL 1100  CITRUS
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-214
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1100 ug  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MALTITOL (UNII: D65DG142WK)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN (UNII: FST467XS7D)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61578-214-0168 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/10/2022
    GEL 1100  GRAPE
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61578-217
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1100 ug  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MALTITOL (UNII: D65DG142WK)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN (UNII: FST467XS7D)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61578-217-0168 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/10/2022
    Labeler - Dental Alliance Holdings LLC (195544965)
    Registrant - Dental Alliance Holdings LLC (195544965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Alliance Holdings LLC195544965manufacture(61578-214, 61578-217, 61578-213)
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