Label: HISMILE- vanilla flavor sodium fluoride anticavity toothpaste gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 15, 2024

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

  • Active ingredient

    Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    When using this product

    • do not swallow
    • do not use in eye area

    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 a day, or use 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 neceaasry until capable of using without supervision.
    • children under 2 years of age: Consult a dentist or doctor.
  • Inactive ingredients

    Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Disodium Phosphate, Flavor, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Caprylyl Glycol, Pentylene Glycol, Benzyl Alcohol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, Titanium Dioxide

  • label

    Vanilla Flavor Sodium Fluoride Anticavity Toothpaste

    Manufactured for:
    Hismile Pty Ltd, 225 Burleigh
    Connection Rd, Burleigh Waters,
    Queensland, Australia 4220.

    Formulated in Australia.
    Made in USA.

    www.hismileteeth.com
    © Hismile Pty Ltd, 2022

    TRUSTED BY DENTISTS

    sugar-free
    cruelty- free
    no SLS & PEGs
    vegan

    Hismile uses the highest quality ingredients to provide a superior clean with oral health benefits. Paired with a refreshing burst of flavor, this toothpaste creates a unique smile care experience.

  • label

    label

  • INGREDIENTS AND APPEARANCE
    HISMILE 
    vanilla flavor sodium fluoride anticavity toothpaste gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83013-320
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83013-320-0660 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/15/2024
    Labeler - Hismile Pty Ltd (758083252)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, LLC061595175manufacture(83013-320)