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

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  • GUM CAVITY PREVENTION FLUORIDE MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]

GUM CAVITY PREVENTION FLUORIDE MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [SUNSTAR AMERICAS, INC.]
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NDC 52376-086-05
Set ID 48236fcc-bb05-4732-888b-a7d9a4b9b4e2
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 the 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 a Poison Control Center right away.

  • Directions

      Adults and children 2 years of age

      and older 

      Brush teeth thoroughly, preferably after each meal or at least

      twice a day, or as directed by a dentist or doctor.

     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

    		  Consult a dentist or doctor.

  • Inactive ingredients

    Sorbitol, Water, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Flavor, Xanthan Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Cellulose Gum, Methylparaben

  • Questions?

    1-800-528-8537 Mon-Fri (7am-6 pm CST)

  • SPL UNCLASSIFIED SECTION

    SUNSTAR

    Manufactured by: Sunstar Americas, Inc., 301 E. Central Road, Schaumburg, IL 60195, U.S.A. TBE000013Z

    GUMbrand.com

    TWIST OFF CAP AND REMOVE SEAL.

    DO NOT USE IF SEAL IS NOT INTACT.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    GUM CAVITY PREVENTION FLUORIDE MINT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52376-086
    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)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52376-086-0524 g in 1 TUBE; Type 0: Not a Combination Product04/01/2018
    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(52376-086)
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