Label: IODENT ANIMAL KINGDOM BUBBLE GUM- sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 5, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                                                           Purpose

    Sodium fluoride 0.22%---------------------------------------------------------------------------Anti-Cavity

    (Available fluoride content:1000 ppm)

  • PURPOSE

    Uses

    Aids in the prevention of dental cavities.

  • WARNINGS

    Warnings

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 6 years of age.

  • INDICATIONS & USAGE

    Direction:

    Aduts 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: Instruct children under 6 years of age to use a pea size amount. Supervise child's brushing and rinsing (to minimize swallowing).

    Children under 2 years of age: Consult a dentist or physician.

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, sorbitol, silica, polyethylene glycol 400, sodium carboxymethylcellulose, sodium lauryl alcohol, gum flavor, titanium dioxide, sodium saccharin, methylparaben, propylparaben, color: pink

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.,

    Cerritos, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    IODENT ANIMAL KINGDOM BUBBLE GUM 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-106
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-106-851 in 1 CARTON
    185 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/13/2014
    Labeler - United Exchange Corp. (840130579)
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