Label: TWICE SCIENCE WELLNESS COOLING SPEARMINT EUCALYPTUS- potassium nitrate, sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Drug Facts

  • Active Ingredients

    Potassium Nitrate 5%

    Sodium Fluoride 0.240% 

    (0.15% w/v fluoride ion)

    Purpose

    Antisensitivity

    Anticavitiy

  • Uses

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

  • 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.

  • Directions

    • Adults and children 12 years of age and olde r: 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.
  • 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, Sodum Benzoate, Citric Acid.

  • Package Labeling:

    Tube

  • INGREDIENTS AND APPEARANCE
    TWICE SCIENCE WELLNESS COOLING SPEARMINT EUCALYPTUS 
    potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72164-004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    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 (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72164-004-011 in 1 BOX01/02/2021
    196 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/02/2021
    Labeler - Smiletwice, Inc. (117404286)
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