CRAYOLA SQUEEZE-A-COLOR- sodium fluoride paste, dentifrice
Sunstar Americas, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Crayola

Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps in the prevention of dental cavities

Warning

Keep out of the 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

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 2 years

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, FD&C Red 40*, FD&C Blue 1*, D&C Yellow 10*, FD&C Blue 1*
* contains one or more of these ingredients.

QUALITY GUARANTEE

Sunstar Americas, Inc. guarantees the quality of this Crayola product. If this product does not perform properly, contact us at 1-800-777-3101. Representatives are available weekdays 7am-6pm CST.

www.crayola.com

OFFICIAL LICENSED PRODUCT

SUNSTAR

G.U.M

GUMbrand.com

Manufactured for:

4635 W. Foster Ave., Chicago, IL 60630 U.S.A.

Made in Canada

SUNSTAR G.U.M CRAYOLA 127.5 g Carton

Principal Display Panel - 127.5 g Carton

CRAYOLA JAZZY APPLE

BLUBERRY BURST

MELON BLAST

Crayola Special Value Pack
[One 1.5 oz(42.5 g) toothpaste and One Toothbrush]

TBTPKIT

CRAYOLA SQUEEZE-A-COLOR
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52376-035
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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 (UNII: K679OBS311)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	green (JAZZY APPLE) , blue (BLUEBERRY BURST) , red (MELON BLAST)	Score
Shape		Size
Flavor	APPLE, BLUEBERRY, WATERMELON (Melon)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52376-035-08	3 in 1 PACKAGE, COMBINATION	07/02/2014	01/31/2019
1		6.5 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
2	NDC:52376-035-02	3 in 1 CARTON	07/02/2014	06/30/2019
2		42.5 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
3	NDC:52376-035-09	1 in 1 KIT	11/20/2014	11/04/2022
3		42.5 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/03/2013	11/04/2022

Labeler - Sunstar Americas, Inc. (025066358)

Name	Address	ID/FEI	Business Operations
Establishment
Sunstar Americas, Inc.		025066358	manufacture(52376-035)

Revised: 11/2022

Document Id: ecaca59c-098a-cf7a-e053-2995a90a4961

Set id: 714fa6e6-2cd5-4df5-bdcc-9c9023ba702f

Version: 7

Effective Time: 20221104

Sunstar Americas, Inc.

Crayola Fluoride Toothpaste