Otc - Active Ingredient
Active ingredient(s)
Sodium Fluoride 0.221%
Cloveden Sensitive Care Tooth Paste, Dentifrice
FDA Label NDC 73242-1113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dong Il Pharms Co.,ltd for the product Cloveden Sensitive Care Tooth (NDC 73242-1113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anti-cavity
Indications & Usage
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
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
If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.
Dosage & Administration
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
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
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