Label: DENTAL CLEAR PREMIUM- sodium fluoride rinse

  • NDC Code(s): 24765-127-01
  • Packager: Pharmacal-International. Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 17, 2023

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  • Active ingredient

    Sodium Fluoride (0.02%)

    Purpose

    • Anticavity mouthwash

    Use

    • Aids in prevention of dental cavities

    Directions

    • Rinse mouth with this Dental Clear Premium about 10~15ml for 30 seconds then expel

    Average daily dose

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

    Warnings

    • Keep out of reach of children.
    • Children under 7 years or younger must have parent supervision.
    • Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Inactive Ingredients

    Water,,Glycerin,Allantoin,Acetic acid,Xylitol,Sodium acetate,Sodium Benzoate,GreenTea Extract,Malic acid,L-Menthol,Propolis Extract,Citrus flavoring,Lemon flavoring,Sodium Saccharin,Lemon Oil,Cacao Color

  • Principal display panel

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  • INGREDIENTS AND APPEARANCE
    DENTAL CLEAR PREMIUM 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MALIC ACID (UNII: 817L1N4CKP)  
    RACEMENTHOL (UNII: YS08XHA860)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    LEMON OIL (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-127-0111 mL in 1 POUCH; Type 0: Not a Combination Product03/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/14/2020
    Labeler - Pharmacal-International. Co., Ltd. (557805060)
    Registrant - Pharmacal-International. Co., Ltd. (557805060)
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