HISMILE- grape bubblegum flavor sodium fluoride anticavity toothpaste gel 
Hismile Pty Ltd

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Grape Bubblegum 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

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

Inactive ingredients

Aqua, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Caprylyl Glycol, Sucralose, Sodium Gluconate, Pentylene Glycol, Methyl Diisopropyl Propionamide, Zinc Lactate, Benzoic Acid, FD&C Red No. 40, FD&C Blue No. 1

label

Grape Bubblegum 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 
grape bubblegum flavor sodium fluoride anticavity toothpaste gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83013-317
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
SORBITOL (UNII: 506T60A25R)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
ZINC LACTATE (UNII: 2GXR25858Y)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Bubblegum Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83013-317-0660 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(83013-317)

Revised: 1/2024
Document Id: 0ef85a9e-7c15-d411-e063-6394a90a20f0
Set id: 0ef6f8b5-8565-b364-e063-6294a90aabbc
Version: 2
Effective Time: 20240115
 
Hismile Pty Ltd