hismile STRAWBERRY FLAVOR anticavity

Manufacturer
HISMILE PTY LTD
Effective date
2023-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:55

Label at a glance#

Producthismile STRAWBERRY 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, 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.

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

strawberry308strawberry308

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83013-308-062025-05-23C16284748780-12cef2736-ae5a-d83d-e063-dadaa90ab31fhismile STRAWBERRY FLAVOR anticavity
83013-308-062025-01-30C16284748780-12cef2736-ae5a-d83d-e063-dadaa90ab31fhismile STRAWBERRY FLAVOR anticavity

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83013-30883013-308-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
361e082f-af7f-2475-e063-6394a90aae8ccf22a0f4-e846-4a89-beae-1b80a30689d42025-05-27WarningsExact identifier
spl set id: cf22a0f4-e846-4a89-beae-1b80a30689d4

Reported adverse events (FAERS/openFDA)#

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