CLOVEDEN TOOTH- sodium monofluorophosphate paste, dentifrice

Cloveden Tooth by

Drug Labeling and Warnings

Cloveden Tooth by is a Otc medication manufactured, distributed, or labeled by Acuseplanet Inc, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient(s)

Sodium Monofluorophosphate 0.76%

PURPOSE

Purpose

Anti-cavity

INDICATIONS & USAGE

Use(s)

■ Keep your teeth white and strong

■ Keep your mouth clean

■ Refresh the inside of the mouth

■ Prevent cavities and remove bad breath caused by fluorine.

■ Increases aesthetic effect

■ Prevention of gingivitis and periodontal inflammation (alveolar abscess)

■ Prevention of periodontal disease

■ Prevention of gum disease

■ Prevention of plaque deposition

■ Removal of plaque (anti-prag)

WARNINGS

Warnings

■ Fluorine content of this toothpaste is 1000 ppm

■ Do not swallow and rinse mouth thoroughly after use.

■ If you experience any problems with your gums or mouth during use,

discontinue use and consult your doctor.

■ For children under 6 years of age, use small amounts of toothpaste.

And use it under the supervision of a guardian to avoid sucking or swallowing.

■ Consult a physician or dentist immediately if a child under 6 years old has

swallowed large quantities.

■ Keep out of the reach of children under 6 years of age.

KEEP OUT OF REACH OF CHILDREN

■ Keep out of the reach of children under 6 years of age.

DOSAGE & ADMINISTRATION

Directions

Brushing the teeth with a suitable amount

OTHER SAFETY INFORMATION

Other Information

■ Airtight container, Store in room temperature (1~30℃)

INACTIVE INGREDIENT

Inactive ingredients

Sorbitol, Hydrated Silica, Water, Glycerin, Xylitol, Cellulose Gum, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Tetrasodium Pyrophosphate, Rubas Idaeus Fruit Extract, Menthol, Mentha Pulegium Oil, Stevioside, Tocopheryl Acetate, Mentha Piperita Oil, Citrus Limon (Lemon) Fruit Oil, Sodium Bicarbonate, Centella Asiatica Extract, Curcuma Longa Root Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Clove Mint Flaovr, Cooling Flavor, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Gardenia Yellow Color, Gardenia Blue Color

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOVEDEN TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84516-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84516-010-02	1 in 1 CARTON	07/01/2024
1	NDC: 84516-010-01	100 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
OTC Monograph Drug	M021	07/01/2024

Labeler - Acuseplanet Inc (987646711)

Registrant - Acuseplanet Inc (987646711)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(84516-010)