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 cavities

Warnings

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

Flip open the cap, and apply thin strip on toothbrush.

  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after meals or at least twice a day, or use as directed by a dentist or physician
  • children 2 to 6 years of age: use only a pea-sized amount and supervise the child’s brushing and rinsing
  • children under 2 years of age: ask a dentist or physician

Inactive ingredients

Water, Sorbitol, Glycerin, Hydrated Silica, Xylitol, Potassium Acesulfame, Xanthan Gum, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Trisodium Phosphate, (Red Paste, FD&C Red 40, Blue paste, FD&C Blue 1, Green Paste, D&C Yellow 10, FD&C Blue 1)

Questions or comments?
QUALITY GUARANTEE

Sunstar Americas, Inc. guarantees the quality of this Crayola product. If this product does not perform properly, contact us in the U.S. at 1-800-777-3101, weekdays 7AM-3PM CST and in Canada at 1-800-265-8353, weekdays 9AM-5PM EST

© Sunstar Americas, Inc.

Chicago, IL 60630 U.S.A.

GUMbrand.com

SUNSTAR G.U.M CRAYOLA 127.5 g Carton

Principal Display Panel - 127.5 g Carton

CRAYOLA JAZZY APPLE

CRAYOLA JAZZY APPLE

BLUBERRY BURST

BLUBERRY BURST

MELON BLAST

MELON BLAST

CRAYOLA  SQUEEZE-A-COLOR
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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
WATER 
SORBITOL 
GLYCERIN 
HYDRATED SILICA 
XYLITOL 
ACESULFAME POTASSIUM 
XANTHAN GUM 
SODIUM LAURYL SULFATE 
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 DescriptionMarketing Start DateMarketing End Date
1NDC:52376-035-023 in 1 CARTON
142.5 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)

Revised: 7/2013
 
Sunstar Americas, Inc.