Label: SPEARMINT WHITENING WITH HEMP OIL- sodium monofluorophosphate paste, dentifrice

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

Drug Label Information

Updated February 13, 2024

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion) ...... Anticavity

  • PURPOSE

    Use aids in the prevention of dental cavities

  • WARNINGS

    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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per 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 INGREDIENT

    Inactive Ingredients glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, cannabis sativa (hemp) seed oil, sodium auroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

  • Principal Display Panel

    Carton R1Spearmint with Fluoride

    Toothpaste

    with Hemp Seed Oil

    Cavity Fighting & Whitening Net wt 5.5 oz (156g)

  • INGREDIENTS AND APPEARANCE
    SPEARMINT WHITENING WITH HEMP OIL 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-0019
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-0019-1156 g in 1 TUBE; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/29/2020
    Labeler - Whole Foods (196175616)
    Registrant - Lornamead (080046441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(42681-0019)
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