Label: QFORET SHARON TOOTHPASTE- sodium monofluorophosphate, silica, alcloxa paste, dentifrice

  • NDC Code(s): 83193-030-01, 83193-030-02
  • Packager: QGENETICS CO.,LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 19, 2023

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  • Active ingredients

    Sodium Monofluorophosphate 0.758%
    Silica 15.00%
    Alcloxa 0.11%

  • Inactive ingredients

    Sorbitol,Glycerin,Cellulose Gum,Algin,Sodium Cocoyl Glutamate,Cocamidopropyl Betaine,Hydroxyapatite,Xylitol,Glucosyl Stevioside,Menthol,Mentha Piperita (Peppermint) Oil,Flavor,Pistacia Lentiscus (Mastic) Gum Oil,Myrrh Tincture,Citrus Grandis (Grapefruit) Seed Extract,Camellia Sinensis Leaf Extract,Chamomilla Recutita (Matricaria) Extract,Salvia Officinalis (Sage) Extract,Panax Ginseng Root Extract,Centella Asiatica Leaf Extract,Licorice Root Extract,Water

  • Purpose

    ANTICAVITY
    ANTI-PLAQUE
    GUM CARE

  • 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 right away.

  • Keep out of reach of children

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

  • Uses

    ■ Aids in the prevention of dental cavities
    ■ Plaque removal (Anti-Plaque)
    ■ Prevention of periodontal disease, prevention of gum disease

  • Directions

    ■ Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

  • Other Information

    ■ Store in an airtight container at room temperature
    ■ Date of use: 36 months from the date of manufacture

  • Question or Comments?

    Email: qgenetics@qgenetics.co.kr

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    QFORET SHARON TOOTHPASTE 
    sodium monofluorophosphate, silica, alcloxa paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83193-030
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15.0 g  in 100 g
    Alcloxa (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) Alcloxa0.11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83193-030-021 in 1 CARTON05/01/2023
    1NDC:83193-030-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2023
    Labeler - QGENETICS CO.,LTD. (694619127)
    Registrant - QGENETICS CO.,LTD. (694619127)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(83193-030)
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