KOSETTE SALT TOOTH- sodium monofluorophosphate paste, dentifrice 
K.Boeun Pharmaceutical Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SODIUM MONOFLUOROPHOSPHATE

ANTI-CAVITY

Keep out of reach of children

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician

Storage method

1. Keep it at room temperature in a classified container.

2. Cover and store at room temperature.

3. Store in a not moisture and cool place.

4. Air may come out during use of this product, but there is no problem with its weight.

Usage Precautions

1. Be careful not to swallow. Rinse mouth thoroughly after use

2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

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

D-Sorbitol Solution, WATER, SILICON DIOXIDE, CONCENTRATED GLYCERIN, SODIUM COCOYL GLUTAMATE, POLYETHYLENE GLYCOL 1500, CARBOXYMETHYLCELLULOSE SODIUM, PEPPERMINT OIL, ACTIVE CARBON, L-MENTHOL, CITRUS PARADISI (GRAPEFRUIT) SEED EXTRACT, XYLITOL, SODIUM CHLORIDE, ENZYMATICALLY MODIFIED STEVIA, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ALOE EXTRACT, SAGE EXTRACT

For dental use only

1

KOSETTE SALT TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74724-0011
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74724-0011-130 g in 1 TUBE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2020
Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
Establishment
NameAddressID/FEIBusiness Operations
K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(74724-0011)

Revised: 5/2020
Document Id: a69ac6f6-aa42-07ab-e053-2a95a90a5b3a
Set id: a69adb68-ba39-8864-e053-2995a90a1da6
Version: 1
Effective Time: 20200527
 
K.Boeun Pharmaceutical Co.,Ltd.