Label: L'ECLAT ROSE TOOTHPASTE- silicon dioxide, xylitol, tocopherol acetate paste, dentifrice

  • 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 July 5, 2019

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  • ACTIVE INGREDIENT

    Active ingredients: Silicon dioxide 12.0%, Xylitol 0.5%, Tocopherol Acetate 0.1%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Sorbitol, Purified Water, Glycerin, Sodium Cocoyl Glutamate, Sodium Cellulose Glycolate, Aroma (Rose Fruits), Menthol, Sodium Benzoate, Stevioside, Hydroxyapatite, Beet Red, Aloe Vera Leaf Extract, Sodium Hydrogen Carbonate, Eucalyptus Extract, Green Tea Extract, Sage Extract, Chamomile Extract, Rosemary Extract, Certified Organic Ingredients

  • PURPOSE

    Purpose: Anti-plaque, Anti-cavity, Anti-gingivitis

  • WARNINGS

    Warnings:
    Keep out of the reach of children under 2 years of age. If you accidentally swallow more than used for brushing, seek professional assistance immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 2 years of age.

  • Uses

    Uses:
    Keep your teeth white and strong.
    Keep your mouth clean.
    Refresh the inside of the mouth.
    To prevent tooth decay and remove bad breath.
    Increase esthetic effect.
    Removal of plaque (anti-plaque).
    Prevention of gingivitis.
    Prevention of Periodontal disease gum disease.

  • Directions

    Directions:

    For best results, brush after every meal and whenever you want your breath to be fresh.
    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 under 2 years: Ask a dentist or physician

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    L'ECLAT ROSE TOOTHPASTE 
    silicon dioxide, xylitol, tocopherol acetate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73175-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silicon dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) Silicon dioxide12.0 g  in 100 g
    Xylitol (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) Xylitol0.5 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73175-010-021 in 1 CARTON06/01/2019
    1NDC:73175-010-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2019
    Labeler - Toaon Co., Ltd. (694977241)
    Registrant - Toaon Co., Ltd. (694977241)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(73175-010)