GUM Crayola Anticavity Fluoride Tropical Twist

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 22:57:32

Label at a glance#

ProductGUM Crayola Anticavity Fluoride Tropical Twist
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Unscrew cap and remove foil seal. Once cap is screwed back into place, flip it open and apply a thin strip of toothpaste on to the toothbrush. 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 physician. children under 6 years of age   Instruct in good brushing and rinsing habits (to minimize swallowin...

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 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 contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Unscrew cap and remove foil seal. Once cap is screwed back into place, flip it open and apply a thin strip of toothpaste on to the toothbrush.

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 physician.

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

2years of age

  ask a dentist or physician

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Water, Glycerin, Xylitol, Xanthan Gum, Potassium Acesulfame, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Trisodium Phosphate, FD&C Blue 1

SPL UNCLASSIFIED SECTION

3+

Helps Prevents Cavities

QUALITY GUARANTEE

Sunstar Americas, Inc.guarantees the quality of this Crayola product. If this product does not perform properly, contact us at 1-888-777-3101. Representatives are available weekdays 7am -6pm CST.

A Hallmark Company        © ​2016 Crayola, Easton, PA 18044-0431

                                        Crayola logo, Cheveron & Serpentine designs are trademarks of Crayola used under license.

Manufactured by : © Sunstar Americas, Inc.

301 East Central Rd., Schaumburg, IL 60195 U.S.A.

GUMbrand.com       www.crayola.com

OFFICIAL LICENSED PRODUCT      Made in U.S.A

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52376-04652376-046-10

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#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ecad02ad-1a3e-a269-e053-2a95a90a34a3ab958a76-e227-48cb-a440-e69971bddc2f2022-11-04WarningsExact identifier
spl set id: ab958a76-e227-48cb-a440-e69971bddc2f

Reported adverse events (FAERS/openFDA)#

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