Label: TOOSTY MINT CHOCOLATE TOOTHPASTE- precipitated calcium carbonate, dicalcium phosphate dihydrate, aluminium chlorohydroxy allantoinate, sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 82662-050-01, 82662-050-02
  • 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

    Precipitated Calcium Carbonate 40%
    Dicalcium Phosphate Dihydrate 0.5%
    Aluminium Chlorohydroxy Allantoinate 0.05%
    Sodium Monofluorophosphate 0.72%

  • INACTIVE INGREDIENTS

    D-Sorbitol Solution,Concentrated Glycerin, Sodium Carboxymethylcellulose, Hydroxyapatite, Xylitol, Stevioside, Silicon Dioxide, Charcoal-Mannitol mix ball, L-Menthol, Sage Extract, Chamomile Extract, Aloe Extract, Menthol Pulegium Oil, Mint-Choco Flavor, Mint-Choco Flavor, Mint Flavor, Mixed green, FD&C Blue No. 1, Cacao Color, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Water

  • PURPOSE

    Antiplaque
    Anticavity
    Gum Care
    Freshen Breath

  • WARNINGS

    ■ The fluoride content of this toothpaste is 950 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

    ■ Mint, xylitol, cacao, and charcoal recipes give you strong freshness and freshness after brushing your teeth
    ■ Improvement of bad breath/reduction of oral bacteria completed clinical verification
    ■ Contains "Sage X, Aloe X, Rosemary X" certified ingredients
    ■ 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)
    ■ Keep your teeth white and strong
    ■ Keep the mouth clean
    ■ Refresh the mouth
    ■ Prevent tooth decay and remove bad breath
    ■ Increase the aesthetic effect
    ■ Prevention of gingivitis, periodontitis (dental fistula), prevention of periodontal disease, gum disease, and dental plaque removal (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 MINT CHOCOLATE TOOTHPASTE 
    precipitated calcium carbonate, dicalcium phosphate dihydrate, aluminium chlorohydroxy allantoinate, sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82662-050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION40.0 g  in 100 g
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE0.5 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.05 g  in 100 g
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.72 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82662-050-021 in 1 CARTON07/01/2023
    1NDC:82662-050-0180 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(82662-050)