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Crayola SQUEEZE-A-COLOR by Sunstar Americas, Inc.

Medically reviewed on November 20, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 0.24mg in 1g
Labeler: Sunstar Americas, Inc.
NDC Code: 52376-035

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.

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:

© Sunstar Americas, Inc.

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

Made in Canada

SUNSTAR G.U.M CRAYOLA 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]

CRAYOLA  SQUEEZE-A-COLOR
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52376-035
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
WATER 
GLYCERIN 
XYLITOL 
XANTHAN GUM 
ACESULFAME POTASSIUM 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
D&C YELLOW NO. 10 
Product Characteristics
Colorgreen (JAZZY APPLE) , blue (BLUEBERRY BURST) , red (MELON BLAST) Score    
ShapeSize
FlavorAPPLE, BLUEBERRY, WATERMELON (Melon) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52376-035-083 TUBE in 1 PACKAGE, COMBINATION
16.5 g in 1 TUBE
2NDC:52376-035-023 TUBE in 1 CARTON
242.5 g in 1 TUBE
3NDC:52376-035-091 TUBE in 1 KIT
342.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/03/2013
Labeler - Sunstar Americas, Inc. (025066358)

 
Sunstar Americas, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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