Label: DR. ZENNI KIDS TOOTH (BABY)- silicon dioxide paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 28, 2021

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  • ACTIVE INGREDIENT

    Silicon Dioxide 6.0%

  • PURPOSE

    Anti plaque

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Uses

    ■ Helps protect against cavities
    ■ Removal of plaque

  • WARNINGS

    Keep out or reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENTS

    D-Sorbitol Solution, Water, Concentrated Glycerin, Xanthangum, Raspberry Flavor, Xylitol, Grapefruit Seed Extract, Chamomile Extract, Sage Extract, Aloe Extract, Eucalyptus Extract, Green Tea Extract, Calendula Extract, Beet Red

  • 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: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
    ■ Children under 2 years: Consult a dentist or doctor.

  • Other Information

    ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light (1~30℃)

  • Questions

    ■ www.zeniton.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR. ZENNI KIDS TOOTH (BABY) 
    silicon dioxide paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73029-0001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73029-0001-160 g in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2019
    Labeler - Zeniton Co.,Ltd. (688416831)
    Registrant - Zeniton Co.,Ltd. (688416831)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(73029-0001)
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