Label: DENTAL CLEAR NATURAL- sodium fluoride rinse

  • 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 December 1, 2011

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  • ACTIVE INGREDIENT

    Sodium Fluoride (0.05%)

    Anticavity Rinse

    Keep out of reach of children.

    Children under 7 years or younger must have parent supervision.

    If one drank a lot of amount, drink some milk and please go see a doctor.

    Keep out of reach of children.

    Use twice a day after brushing, meals, and before social occasions.

    Rinse mouth with this Dental Clear Natural about 10 -15 ml for 30 seconds and expel.

    Water

    L-Menthol

    Glycerin

    Acetic Acid

    Sodium Acetate

    Camellia Sinensis leaf Extract

    Saccharin sodium

    Sodium benzoate

    Xylitol

    Poloxamer

    Citrus Medica Limonum Peel Oil

    Malic Acid

    Propolis Exxtract

  • PRINCIPAL DISPLAY PANEL

    Image

  • INGREDIENTS AND APPEARANCE
    DENTAL CLEAR NATURAL 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium fluoride0.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    CAMELLIA SINENSIS ROOT (UNII: 8H54O0V2K3)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    MALIC ACID (UNII: 817L1N4CKP)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-100-01260 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2011
    Labeler - Pharmacal-International. Co., Ltd. (557805060)
    Registrant - Pharmacal-International. Co., Ltd. (557805060)
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