TOOSTY RUCOLA TOOTHPASTE- silicon dioxide, sodium monofluorophosphate, sodium pyrophosphate, tocopherol acetate paste, dentifrice 
Headquarter Co., Ltd

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.

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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

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)

Revised: 7/2023
Document Id: c3bc04a8-1b36-464f-8fa3-c7717b96b936
Set id: d48bbabf-cd3e-4f4e-accb-cf46cdd088be
Version: 1
Effective Time: 20230726
 
Headquarter Co., Ltd