Label: TOOSTY RUCOLA TOOTHPASTE- silicon dioxide, sodium monofluorophosphate, sodium pyrophosphate, tocopherol acetate paste, dentifrice

  • NDC Code(s): 82662-020-01, 82662-020-02
  • Packager: Headquarter 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 July 26, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Silicon Dioxide 17%
    Sodium Monofluorophosphate 0.76%
    Sodium Pyrophosphate 0.5%
    Tocopherol Acetate 0.2%

  • INACTIVE INGREDIENTS

    Sodium Carboxymethylcellulose, D-Sorbitol Solution, Concentrated Glycerin, Xylitol, Stevioside, Olea Europaea Leaf Extract, Parsley Extract, Green Tea Extract, Sage Extract, Aloe Extract, Lactuca Scariola Sativa Leaf Extract, Rosemary Extract, Calendula Extract, L-Menthol, Rucola Flavor, Patchouli Flavor, Gardenia Yellow Color, Gardenia Blue Color, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Water

  • PURPOSE

    Antiplaque
    Anticavity
    Gum Care
    Freshen Breath

  • WARNINGS

    ■ The fluoride content of this toothpaste is 1000 PPM
    ■ Be careful not to swallow, and rinse the mouth thoroughly after use
    ■ If the use of this toothpaste causes abnormalities, such as damage to the gums or mouth, stop using it and consult with a doctor or dentist
    ■ When used by a child under the age of 6, a small amount of toothpaste the size of a pea at a time shall be used under the guidance of the guardian to prevent sucking or swallowing
    ■ If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately
    ■ Keep out of reach of children under the age of 6

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under the age of 6

  • Uses

    ■ Premium toothpaste for freshen bad breath and prevent dental plaque
    ■ It contains tartar-inhibiting ingredient "TSPP (Sodium Pyrophosphate)" to prevent tartar from accumulating (KFDA certified ingredient)
    ■ It contains natural surfactant derived from coconut, which makes your mouth less dry and keeps your mouth moist
    ■ 14 Hazardous Ingredients-Free (paraben, synthetic preservative, microbeads, synthetic surfactant, mineral oil, triclosan, human harmful scent, PEG/PG, saccharin, polypropylene, MIT/CMIT, polyethylene, artificial pigment)
    ■ Vegan toothpaste officially certified by the Korea Institute of Vegan Certification
    ■ Keep your teeth white and strong
    ■ Keep the mouth clean
    ■ Refresh the mouth
    ■ Fluorine prevents tooth decay and removes bad breath
    ■ increase the aesthetic effect
    ■ Prevention of gingivitis (diastolic fistula), prevention of periodontal disease, prevention of gum disease, prevention of tartar deposition, and removal of plaque (anti-plaque)

  • Directions

    ■ Use adequate amount of toothpaste on a toothbrush to brush your teeth and rinse off with water.

  • Other Information

    ■ Store in room temperature (1-30℃ or 33.8-86℉)

  • Questions

    ■ www.toosty.kr

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TOOSTY RUCOLA TOOTHPASTE 
    silicon dioxide, sodium monofluorophosphate, sodium pyrophosphate, tocopherol acetate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82662-020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) Silicon Dioxide17.0 g  in 100 g
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Sodium Pyrophosphate (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) Sodium Pyrophosphate0.5 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82662-020-021 in 1 CARTON07/01/2023
    1NDC:82662-020-0180 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2023
    Labeler - Headquarter Co., Ltd (695142150)
    Registrant - Headquarter Co., Ltd (695142150)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(82662-020)