Label: 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

    Anticavity

  • 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 older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly after meals or at least twice a day or as recommended by a dentist or doctor. Make sure to brush sensitive areas of the teeth. Minimize swallowing.

    • Children under 12 years: consult a dentist or doctor.

  • Inactive Ingredients

    • Water, Hydrated Silica, Sorbitol, Glycerin (Vegetable), Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, 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.

  • Package Labeling:

    Label03Label04

  • INGREDIENTS AND APPEARANCE
    SPEARMINT EUCALYPTUS 
    potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72164-006
    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
    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)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72164-006-0096 g in 1 TUBE; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/01/2022
    Labeler - Smiletwice, Inc. (117404286)
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