Label: 3SECONDS MAGIC GARGLE LEMON- sodium fluoride tablet

  • 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 February 9, 2020

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  • ACTIVE INGREDIENT

    Sodium Flouride

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    1. Put one tablet in mouth.

    2. Chew it.

    3. Gargle for 30 sec.

    4. Spit it out.

    5. Rinse with water.

  • WARNINGS

    1. The fluoride concentration of this toothpaste is 583.21 ppm.

    2. Be careful not to swallow it, and rinse your mouth thoroughly after use.

    3. If a child under 6 years of age swallows a large amount, consult a doctor or dentist immediately.

    4. Keep out of reach of children under 6 years old.

  • INACTIVE INGREDIENT

    MALIC ACID, HYPROMELOSE, MALTITOL, SAGE EXTRACT, XYLITOL, GREEN TEA EXTRACT, MENTHOL, MINT FLAVOR, LEMON FLAVOR, RED MINT FLAVOR, PEPPERMINT FLAVOR, ETC.

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    3SECONDS MAGIC GARGLE LEMON 
    sodium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73587-0010
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 mg
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize14mm
    FlavorLEMONImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73587-0010-118 in 1 BOX01/01/2020
    11 in 1 DOSE PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2020
    Labeler - SUNJINBIO CO.,LTD (695626316)
    Registrant - SUNJINBIO CO.,LTD (695626316)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUNJINBIO CO.,LTD695626316manufacture(73587-0010)
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