Label: SALTRAIN TOOTH- sodium monofluorophosphate paste
- NDC Code(s): 74724-0021-1
- 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 November 11, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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INACTIVE INGREDIENT
Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate, D-Sorbitol Solution, Concentrated Glycerin, Polyethylene Glycol 1500, Xanthangum, Sodium Cocoyl Glutamate, Silicon Dioxide, Titanium Oxide, Enzymatically Modified Stevia, Xylitol, Sodium Chloride, Ascorbic Acid, Mentha Oil, l-Menthol, Spearmint Oil, Water
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SALTRAIN TOOTH
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74724-0021 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.4 g in 100 g Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) AMINOCAPROIC ACID (UNII: U6F3787206) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74724-0021-1 100 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/01/2020 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(74724-0021)