Label: MEDIF TOOTH- silicon dioxide, alcloxa paste, dentifrice

  • NDC Code(s): 72346-010-01, 72346-010-02
  • Packager: MEDIF CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 24, 2023

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  • ACTIVE INGREDIENT

    Active ingredients: SILICON DIOXIDE 14.0%, ALCLOXA 0.05%

  • INACTIVE INGREDIENT

    Inactive ingredients: D-Sorbitol Solution, Propolis Powder, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xantangum, L-Menthol, Peppermint Oil, Charcoal, Grapefruit Seed Extract, Hydroxyapatite, Xylitol, Anetol Oil, Glucosyl Stevia, Chamomile Extract, Eucalyptus Extract, Sage Extract, Aloe Extract, Glycyrrhiza Extract Powder, Silver foil, Water

  • PURPOSE

    Purpose: Anticarries

  • WARNINGS

    Warnings: Keep out of the 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 right away.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses: Helps protect against cavities.

  • Directions

    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 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: Ask a dentist or physician

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MEDIF TOOTH 
    silicon dioxide, alcloxa paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72346-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE18.20 g  in 130 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.06 g  in 130 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72346-010-021 in 1 CARTON05/01/2018
    1NDC:72346-010-01130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2018
    Labeler - MEDIF CO.,LTD (694955391)
    Registrant - MEDIF CO.,LTD (694955391)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(72346-010)