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

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

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Drug Label Information

Updated November 29, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: Silica 15.00%, Alcloxa 0.16%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Sorbitol, Water, Glycerin, Mica, Sodium Cocoyl Glutamate, Mentha Piperita, (Peppermint) Oil, Cellulose Gum, Stevioside, Menthol, Xylitol, Glycyrrhiza, Uralensis (Licorice) Root Extract, Gentiana Lutea Root Extract, Sophora Flavescens Root Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis, Pistacia Lentiscus (Mastic) Gum , Salvia Officinalis, (Sage) Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Chitosan, Chamaecyparis, Obtusa Oil, Propolis Extract, Charcoal Powder, Scutellaria Root Extract, Anethole, Hydroxyapatite, Silver

  • PURPOSE

    Purpose: Anticavity

  • WARNINGS

    Warnings:

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

    If you accidentally swallow more than used for brushing, Seek professional help or contact a poison control center immediately.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses:

    Aids in the prevention of cavities, plaque, and gingivitis.

  • Directions

    Directions:

    Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Do not swallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FINEFRA TOOTH 
    silicon dioxide, alcloxa paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69653-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15.0 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69653-050-021 in 1 CARTON05/01/2018
    1NDC:69653-050-01100 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 - Jewoo Medical Co,.Ltd (689512541)
    Registrant - Finefrajapan Co.,ltd. (693542047)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEO-MEDICALFARM CO.,LTD694914835manufacture(69653-050)
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