Label: BRUSHBUDDIES SHOPKINS ANTICAVITY FLUORIDE- sodium fluoride mouthwash

  • 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 3, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient

    Sodium Fluoride 0.05%

  • PURPOSE

    Purpose:

    Anticavity

  • INDICATIONS & USAGE

    Uses:

    Helps protect against cavities

  • WARNINGS

    Warnings:

    If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children 6 years and older:
    • Use daily after your normal brush
    • Shake well before each use
    • Rinse or gargle for 30 seconds with 15 mL (3 teaspoonful) and then spit out
    • Supervise children's brushing untill good habits are established.
    • Do not Swallow the rinse

  • STORAGE AND HANDLING

    Other Information

    Store in cool and dry place away from direct sun light

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Xylitor, Flavor, Acesulfame, Sodium Benzoate, Saccharin Sodium, Rose Red 1

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BRUSHBUDDIES SHOPKINS ANTICAVITY FLUORIDE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-502
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0225 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ACESULFAME (UNII: MA3UYZ6K1H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ROSE BENGAL AT (UNII: 1IID5XA5GB)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-502-01500 g in 1 BOTTLE; Type 0: Not a Combination Product12/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/28/2016
    Labeler - Ashtel Studio Inc (148689180)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Nanhai JiaChun Biology Engineering Co., Ltd527935253manufacture(70108-502)
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