Label: KOSETTE SALT TOOTH- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 74724-0011-1
- Packager: K.Boeun Pharmaceutical Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 27, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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.
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INACTIVE INGREDIENT
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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KOSETTE SALT TOOTH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74724-0011 Route of Administration DENTAL 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 XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74724-0011-1 30 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/01/2020 Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074) Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074) Establishment Name Address ID/FEI Business Operations K.Boeun Pharmaceutical Co.,Ltd. 695674074 manufacture(74724-0011)
