CRAYOLA ANTICAVITY FLUORIDE FRUIT EXPLOSION- sodium fluoride paste, dentifrice

Crayola Anticavity Fluoride FRUIT EXPLOSION by

Drug Labeling and Warnings

Crayola Anticavity Fluoride FRUIT EXPLOSION by is a Otc medication manufactured, distributed, or labeled by Sunstar Americas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Fluoride 0.24%

(0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps in the prevention of dental cavities

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

Directions:

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

• adults and children 2 years of ageand older: brush teeth thoroughly, preferably after each meal or

  at least twice a day, or use as directed by a dentist or physician

• children under6 years of age:

  Instruct in good brushing and rinsing habits (to minimize swallowing).

  Supervise children as necessary until capable of using without supervision

• children under2years of age: ask a dentist or physician

Inactive ingredients:

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

SPL UNCLASSIFIED SECTION

3+

Helps Prevent 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 © 2018 Crayola, Easton, PA 18044-0431

Crayola logo, Chevron & 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

INGREDIENTS AND APPEARANCE

CRAYOLA ANTICAVITY FLUORIDE FRUIT EXPLOSION 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52376-049
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52376-049-11	119 g in 1 TUBE; Type 0: Not a Combination Product	04/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/02/2018

Labeler - Sunstar Americas, Inc. (025066358)

Establishment
Name	Address	ID/FEI	Business Operations
Sunstar Americas, Inc.		025066358	manufacture(52376-049)