Label: SALTRAIN TOOTH- sodium monofluorophosphate, precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice

  • NDC Code(s): 74724-0029-1
  • Packager: K.Boeun Pharmaceutical Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 30, 2021

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  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate, Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

  • INACTIVE INGREDIENT

    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

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

  • WARNINGS

    Warnings

    Keep out of reach of children

    ■ If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Other Information

    ■ Store in an airtight container at room temperature

    ■ Date of use : 36 months from the date of manufacture

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SALTRAIN TOOTH 
    sodium monofluorophosphate, precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74724-0029
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.4 g  in 100 g
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS0.07 g  in 100 g
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE36 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA0.06 g  in 100 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.06 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74724-0029-1180 g in 1 TUBE; Type 0: Not a Combination Product11/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/30/2021
    Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
    Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(74724-0029)
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