HISMILE

Manufacturer
HISMILE PTY LTD | Accupac LLC
Effective date
2024-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:57:52

Label at a glance#

ProductHISMILE
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal of at least twice a day, or use as directed by a dentist of 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243%

(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

Warnings

When using this product

OTC - WHEN USING SECTION

Do not swallow

Do not use in eye area

Keep out of the reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help of contact 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 of at least twice a day, or use as directed by a dentist of 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Glycerin, Hydrated Silica, Xylitol, Sodium Phosphate, Xanthan Gum, Sodium Lauroyl Sarcosinate, Tetrapotassium Pyrophosphate, 1,2-Hexanediol, Cellulose Gum, Sucralose, Lauryl Glucoside, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Iron Oxides

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wonka LabelWonka Label

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83013-32583013-325-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
486df519-5c73-c270-e063-6394a90aa84b1deefb12-616b-a1c2-e063-6294a90aed4d2026-01-15WarningsExact identifier
spl set id: 1deefb12-616b-a1c2-e063-6294a90aed4d
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d458ccc-8f1e-f9c8-e063-6294a90a8da42026-01-15WarningsExact identifier
ndc (product): 83013-325

Reported adverse events (FAERS/openFDA)#

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