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

Toosty Rucola Toothpaste by

Drug Labeling and Warnings

Toosty Rucola Toothpaste by is a Otc medication manufactured, distributed, or labeled by Headquarter Co., Ltd, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82662-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	Silicon Dioxide	17.0 g  in 100 g
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g
Sodium Pyrophosphate (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	Sodium Pyrophosphate	0.5 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82662-020-02	1 in 1 CARTON	07/01/2023
1	NDC: 82662-020-01	80 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2023

Labeler - Headquarter Co., Ltd (695142150)

Registrant - Headquarter Co., Ltd (695142150)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(82662-020)