Label: DR. ZENNI JUNIOR TOOTHPASTE(LIME FLAVOR)- sodium monofluorophosphate paste, dentifrice

  • 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 December 28, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate 0.75%

  • PURPOSE

    Anticavity

  • 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, Silicon Dioxide, Concentrated Glycerin, Hydroxyapatite, Sodium Cocoyl Glutamate, Xanthangum, Xylitol, Grapefruit Seed Extract, Apple-Mint Flavor, Lime Flavor, Peppermint Oil, Sodium Chloride, Chamomile Extract, Sage Extract, Aloe Extract, Eucalyptus Extract, Green Tea Extract

  • 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 JUNIOR TOOTHPASTE(LIME FLAVOR) 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73029-0004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.379 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73029-0004-160 g in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/01/2019
    Labeler - Zeniton Co.,Ltd. (688416831)
    Registrant - Zeniton Co.,Ltd. (688416831)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(73029-0004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!