GUM CRAYOLA ANTICAVITY FLUORIDE TROPICAL TWIST (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]

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  • GUM CRAYOLA ANTICAVITY FLUORIDE TROPICAL TWIST (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]

GUM CRAYOLA ANTICAVITY FLUORIDE TROPICAL TWIST (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]
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NDC 52376-046-10
Set ID ab958a76-e227-48cb-a440-e69971bddc2f
Category HUMAN OTC DRUG LABEL
Packager Sunstar Americas, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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  • Drug Facts

  • Active ingredient

    Sodium Fluoride 0.24%

    (0.14% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    helps in prevention of dental cavities

  • Warnings

  • Keep out of 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

    2years 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 Blue 1

  • SPL UNCLASSIFIED SECTION

    3+

    Helps Prevents 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        © ​2016 Crayola, Easton, PA 18044-0431

                                            Crayola logo, Cheveron & 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

    image description

  • INGREDIENTS AND APPEARANCE
    GUM CRAYOLA ANTICAVITY FLUORIDE TROPICAL TWIST 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52376-046
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52376-046-10119 g in 1 TUBE; Type 0: Not a Combination Product04/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/01/2018
    Labeler - Sunstar Americas, Inc. (025066358)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunstar Americas, Inc.025066358manufacture(52376-046)
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