Cloveden Sensitive Care Tooth

Manufacturer
Acuseplanet Inc | DONG IL PHARMS CO., LTD.
Effective date
2024-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:26

Label at a glance#

ProductCloveden Sensitive Care Tooth
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(s)

Sodium Fluoride 0.221%

OTC - PURPOSE SECTION

Purpose

Anti-cavity

INDICATIONS & USAGE SECTION

Use(s)

■ Protection of sensitive teeth

■ Removal of plaque (anti-prag)

■ Prevention of Tooth decay by Fluoride

■ Keep your teeth white and strong

■ Keep your mouth clean

■ Refresh the inside of the mouth

■ Removes bad breath

■ Increases aesthetic effect

WARNINGS SECTION

Warnings

■ Do not do the following while using this products
Do not use it except for brushing teeth.
■ Other precautions to be taken when using non-medical products
1) The fluoride content of this toothpaste is 1,000 ppm (the total content must be 1,000 ppm or less).
2) If used by children under the age of six, use a small amount of toothpaste about the size of peas per use, and have it used under the guidance of a guardian to prevent washing or swallowing.
3) If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.
■ Storage precautions
1) Store out of reach of children under the age of six.
2) Remove the non-drug from the original container and store it in another container, which can cause accidents or poor product quality due to misuse, so put it in the original container and keep it closed tightly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

■ Apply an appropriate amount to a toothbrush twice a day (morning and evening) and brush your teeth by brushing.

OTHER SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sorbitol, Hydrated Silica, Water, Hydroxyapatite, Potassium Nitrate, Glycerin, Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Methyl Cocoyl Taurate, Xylitol, Menthol, Stevioside, Mentha Pulegium Oil, Mentha Piperita Oil, Cooling Flavor, Mint Flavor, Sodium Chloride, Clove Mint Flaovr, Tocopheryl Acetate, Eugenia Caryophyllus (Clove) Flower Oil, Salvia Officinalis Leaf Extract, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Calendula Officinalis Flower Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2701521sodium fluoride 0.221 % ToothpastePSN1
2701521sodium fluoride 0.00221 MG/MG ToothpasteSCD1
2701521sodium fluoride 0.221 % ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84516-020-01Cloveden Sensitive Care Tooth100 g in 1 TUBEPASTE, DENTIFRICE1001
84516-020-02Cloveden Sensitive Care Tooth1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84516-020CLOVEDEN SENSITIVE CARE TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [ACUSEPLANET INC]12 package rows20240718_1d6e9687-5882-effd-e063-6294a90ab756.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84516-02084516-020-01, 84516-020-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1d6e9687-5883-effd-e063-6294a90ab7561d6e9687-5882-effd-e063-6294a90ab7562024-07-17WarningsExact identifier
spl id: 1d6e9687-5883-effd-e063-6294a90ab756
spl set id: 1d6e9687-5882-effd-e063-6294a90ab756

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.