Label: SCHMIDTS WONDERMINT TOOTH AND MOUTH- potassium nitrate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 June 13, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Potassium Nitrate (5%) w/w

  • Purpose

    Tooth desensitizer

  • Use

    Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

  • Warnings

    Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

    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 12 years of age and older:
    Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a Dentist or Physician. Make sure to brush all sensitive areas of the teeth.
    Children under 12 years of age:
    Consult a Dentist or Physician.

  • Inactive Ingredients

    Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Natural Flavor, Sodium Methyl Cocoyl Taurate, Xanthan Gum, Magnolia Acuminata (Magnolia Bark) Extract, Lycium Barbarum (Goji Berry) Extract, Punica Granatum (Pomegranate) Seed Extract, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis (Aloe Vera) Leaf Extract, Mixed Tocopherols (Sunflower-derived), Stevia Rebaudiana Leaf/Stem Extract, Sodium Bicarbonate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Coenzyme Q10, Zinc Gluconate, Potassium Sorbate, Sodium Benzoate.

  • Questions:

    855.866.9748

  • SPL UNCLASSIFIED SECTION

    SENSITIVITY RELIEF

    TOOTHPASTE FOR SENSITIVE TEETH

    WITH VITAMIN E AND BOTANICAL EXTRACTS

    FLUORIDE FREE | SLS FREE | NO ARTIFICIAL FLAVORS

    √ PEG FREE √ DYE FREE

    CERTIFIED VEGAN & CRUELTY-FREE.

    DIST. BY ©SCHMIDT'S | PORTLAND, OR 97209, USA
    SCHMIDTS.COM

  • Packaging

    label

  • INGREDIENTS AND APPEARANCE
    SCHMIDTS  WONDERMINT TOOTH AND MOUTH
    potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72916-210
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE6.662 g  in 133 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MAGNOLIA ACUMINATA BARK (UNII: 2U55IJZ60C)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    POMEGRANATE SEED (UNII: 7294Z34NS7)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Wondermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72916-210-051 in 1 CARTON06/20/2019
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/20/2019
    Labeler - Schmidt's Naturals (088112308)