Label: 100 TOOTHPAST E MORNING- 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

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  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate 0.75%

  • INACTIVE INGREDIENTS

    D-Sorbitol Solution, Aqua, Silicon Dioxide, Sodium Cocoyl Glutamate, Carboxymethylcellulose Sodium, L-Menthol, Peppermint Oil, Aloe Extract, Spearmint Oil, Titanium Oxide, Soda Flavor, Xylitol, Enzymatically Modified Stevia, Grapefruit Seed Extract,Hydroxyapatite, Sage Extract, Chamomile Extract

  • PURPOSE

    Anti cavity

  • WARNINGS

    Adults and children 2 years of age and older: apply a 1-inch strip of product onto a toothbrush. Brush teeth thoroughly for 3 minutes three times a day (morning, afternoon, evening) or as recommended by a dentist. Do not swallow.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    ■ Helps fight and protect against cavities for healthier teeth.

    ■ Refreshes your day with a strong mint flavor, which leaves your 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 only 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
    100 TOOTHPAST E MORNING 
    sodium monofluorophosphate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81307-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81307-010-021 in 1 CARTON12/01/2020
    1NDC:81307-010-01100 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(81307-010)
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