HISMILE- strawberry flavor sodium fluoride anticavity toothpaste gel 
Hismile Pty Ltd

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Strawberry Flavor Sodium Fluoride Anticavity Toothpaste

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warinings

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

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

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, D&C Red No. 33

Other information

Strawberry 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

HISMILE 
strawberry flavor sodium fluoride anticavity toothpaste gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83013-318
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SORBITOL (UNII: 506T60A25R)  
ZINC LACTATE (UNII: 2GXR25858Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XYLITOL (UNII: VCQ006KQ1E)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83013-318-0660 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(83013-318)

Revised: 1/2024
Document Id: 0ef92984-5698-dc89-e063-6294a90ad7dc
Set id: 0ef766ae-754a-f185-e063-6294a90a3299
Version: 3
Effective Time: 20240115
 
Hismile Pty Ltd