GUM Cavity Prevention Fluoride Mint

Manufacturer
Sunstar Americas, Inc.
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:57:30

Label at a glance#

ProductGUM Cavity Prevention Fluoride Mint
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 as directed by a dentist or doctor.  Children under 6 years of age   Instruct 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 0.24% (0.14% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps in the prevention of dental cavities

WARNINGS SECTION

Warnings

Keep out of 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 or 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 as directed by a dentist or doctor.

 Children under 6 years of age

  Instruct 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

Sorbitol, Water, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Flavor, Xanthan Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Cellulose Gum, Methylparaben

Questions?

OTC - QUESTIONS SECTION

1-800-528-8537 Mon-Fri (7am-6 pm CST)

SPL UNCLASSIFIED SECTION

SUNSTAR

Manufactured by: Sunstar Americas, Inc., 301 E. Central Road, Schaumburg, IL 60195, U.S.A. TBE000013Z

GUMbrand.com

TWIST OFF CAP AND REMOVE SEAL.

DO NOT USE IF SEAL IS NOT INTACT.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52376-08652376-086-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
ecacd6de-932e-3910-e053-2a95a90a361b48236fcc-bb05-4732-888b-a7d9a4b9b4e22022-11-04WarningsExact identifier
spl set id: 48236fcc-bb05-4732-888b-a7d9a4b9b4e2

Reported adverse events (FAERS/openFDA)#

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