Label: 4 PACK- potassium nitrate, sodium fluoride

  • NDC Code(s): 72164-000-00, 72164-001-00, 72164-101-04
  • Packager: Twice Smiles LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 7, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts
  • Active ingredients

    Potassium Nitrate 5%
    Sodium Fluoride 0.240% (0.15% w/v Fluoride ion)

    Purpose

    Antihypersensitivity

    Anticavity

    Close
  • Uses

    Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    Aids in prevention of dental cavities.

    Close
  • Warnings

    When using this product,

    if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

    Stop use and ask a dentist

    if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Keep out of reach of children.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.

    Close
  • Inactive Ingredients

    Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Ascorbyl Phosphate (Vitamin C),
    Retinyl Palmitate (Vitamin A),Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

    Close
  • Drug Facts
  • Active ingredients

    Potassium Nitrate 5%
    Sodium Fluoride 0.240% (0.15% w/v Fluoride ion)

    Purpose

    Antihypersensitivity

    Anticavity

    Close
  • Uses

    Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    Aids in prevention of dental cavities.

    Close
  • Warnings

    When using this product

    if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

    Stop use and ask a dentist

    if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Keep out of reach of children.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.

    Close
  • Inactive Ingredients

    Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Acorbyl Phosphate (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

    Close
  • Twilight Peppermint with Vanilla and Lavender Toothpaste, 96g (72164-000-00)
  • Early Bird Wintergreen and Peppermint Toothpaste 96g (72164-001-00)
  • INGREDIENTS AND APPEARANCE
    4 PACK 
    potassium nitrate, sodium fluoride kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:72164-101
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72164-101-04 1 in 1 KIT 09/14/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 TUBE 192 g
    Part 2 2 TUBE 192 g
    Part 1 of 2
    TWILIGHT PEPPERMINT WITH VANILLA AND LAVENDER 
    potassium nitrate, sodium fluoride paste
    Product Information
    Item Code (Source) NDC:72164-000
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72164-000-00 2 in 1 BOX
    1 96 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 09/14/2018
    Part 2 of 2
    EARLY BIRD WINTERGREEN AND PEPPERMINT 
    potassium nitrate, sodium fluoride paste
    Product Information
    Item Code (Source) NDC:72164-001
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72164-001-00 2 in 1 BOX
    1 96 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 09/14/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 09/14/2018
    Labeler - Twice Smiles LLC (081061747)
    Close