hismile SMOOTH MINT FLAVOR anticavity

Manufacturer
HISMILE PTY LTD
Effective date
2025-05-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:38:40

Label at a glance#

Producthismile SMOOTH MINT FLAVOR anticavity
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

• 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.

Storage and handling

store in a cool, dry place.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

When using this product• do not swallow • do not use in eye area

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

store in a cool, dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

smoothmintsmoothmint

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83013-304-062025-05-23C16284748780-12cef2736-afe3-d83d-e063-dadaa90ab31fhismile SMOOTH MINT FLAVOR anticavity
83013-304-062025-01-30C16284748780-12cef2736-afe3-d83d-e063-dadaa90ab31fhismile SMOOTH MINT FLAVOR anticavity

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83013-304HISMILE SMOOTH MINT FLAVOR ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HISMILE PTY LTD]4Legacy NDC20250529_da11d711-19db-4b05-bb4f-c388db5f5c32.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83013-30483013-304-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
361dff37-1780-a101-e063-6294a90a11fdda11d711-19db-4b05-bb4f-c388db5f5c322025-05-27WarningsExact identifier
spl id: 361dff37-1780-a101-e063-6294a90a11fd
spl set id: da11d711-19db-4b05-bb4f-c388db5f5c32

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.