GUM (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]

GUM (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]
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NDC 52376-036-02
Set ID 0a1e9544-c6d3-43cf-b6e7-7f927e6bd72f
Category HUMAN OTC DRUG LABEL
Packager Sunstar Americas, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
  • DRUG FACTS:

    Active Ingredient

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

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use: helps in prevention of cavities.

  • WARNINGS

    Warnings:Keep out of reach of children under six year of age. if more than use for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions-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 a physician. To minimize swallowing for children under 6,use only pea-sized amount and supervise the child's brushing.

  • KEEP OUT OF REACH OF CHILDREN

    Children under 2 years of age ask a dentist or physician

  • INACTIVE INGREDIENT

    Inactive Ingredients:Sorbitol, Silica, Purified Water, Glycerin, PEG-12, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, Cellulose, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin

    TWIST OFF CAP AND REMOVE FOIL SEAL. DONOT USE IF FOIL IS NOT INTACT.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Sunstar Americas, In.

    Chicago, IL 60630, U.S.A., 

    Made in U.S.A.

    GUMbrand.com

    DOC02399

    P13190

  • PRINCIPAL DISPLAY PANEL

    SUNSTAR

    G.U.M®CAVITY PROTECTION                                        1746

    HEALTHY GUMS. HEALTHY LIFE®                                                DOC02399

    Fluoride Toothpaste                                                       P13190

    0.85 oz/18 mL/Cont.net 24g

    gum toothpaste

  • INGREDIENTS AND APPEARANCE
    GUM 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52376-036
    Route of AdministrationDENTAL
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52376-036-0224 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2013
    Labeler - Sunstar Americas, Inc. (025066358)

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