HISMILE RED VELVET FLAVOR ANTICAVITY- sodium fluoride paste, dentifrice 
HISMILE PTY LTD

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.

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 hismile RED VELVET FLAVOR anticavity

Drug Facts

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 necessary until capable of using without supervision. • children under 2 years of age: Consult a dentist or doctor.

Other information

store in a cool, dry place.

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Pentylene Glycol, Caprylyl Glycol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, Calcium Glycerophosphate, D&C Red No.33.

Questions or comments?

+1-302-440-3558
You may also report serious side effects to this phone number.

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

Formulated in Australia.
Made in Thailand.

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.

Packaging

redvelvet

HISMILE RED VELVET FLAVOR ANTICAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83013-306
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
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
ZINC LACTATE (UNII: 2GXR25858Y)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHOCOLATE (RED VELVET) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83013-306-0660 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/13/2023
Labeler - HISMILE PTY LTD (758083252)

Revised: 1/2023
Document Id: 50ef297e-1ebd-44df-9bf5-d764e2051163
Set id: a2664194-7f59-4e6f-81b2-4fee74a1f876
Version: 1
Effective Time: 20230113
 
HISMILE PTY LTD