CRAYOLA SQUEEZE-A-COLOR- sodium fluoride paste, dentifrice

Crayola by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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]

INGREDIENTS AND APPEARANCE

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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
3		42.5 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/03/2013

Labeler - Sunstar Americas, Inc. (025066358)