Label: TEEN TOOTHPAST E PEACH LEAF FLAVOR- sodium monofluorophosphate gel, 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 23, 2020

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

  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate 0.758%

  • INACTIVE INGREDIENTS

    Precipitated Calcium Carbonate, D-Sorbitol Solution, Water, Hydroxyapatite, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthangum, Xylitol, Peach Leaf Mint Flavor, L-Menthol, Enzymatically Modified Stevia, Sodium Chloride, Grapefruit Seed Extract, Sage Extract, Aloe Extract, Eucalyptus Extract, Chamomile Extract, Green Tea Extract

  • PURPOSE

    Anti cavity

  • 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 contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    ■ Helps fight and protect against cavities for healthier teeth.
    ■ Refreshes a day with eucalyptus flavor, which leaves the mouth feeling fresh and clean.

  • Directions

    ■ Adults and children 2 years of age and older: Brush teeth thoroughly. preferably .after each meal or three times a day, or as directed by a dentist or physician
    ■ Children 2 to 6 years: Use a pea sized amount and supervise child's brushing and rinsing. (to minimize swallowing)
    ■ Children under 2 years: Consult a dentist.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TEEN TOOTHPAST E PEACH LEAF FLAVOR 
    sodium monofluorophosphate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81307-050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.758 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Calcium Carbonate (UNII: H0G9379FGK)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81307-050-021 in 1 CARTON12/01/2020
    1NDC:81307-050-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2020
    Labeler - MGRU (695672240)
    Registrant - MGRU (695672240)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(81307-050)