Label: AQUAPICK WHITENING BUBBLEPICK- sodium fluoride liquid

  • Category: HUMAN OTC DRUG LABEL

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 May 2, 2013

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  • ACTIVE INGREDIENT

    sodium fluoride


  • INACTIVE INGREDIENT

    allantoin, xylitol, greentea extract, sage extract, chamomile extract, grapefruit seed extract


  • PURPOSE

    Clean and maintain the aesthetics and health of teeth including but not warranted to the prevention of gingival and periodontal disease

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    brush with toothbrush and rinse thoroughly



  • WARNINGS

    - Children under the age of 6 should be accompanied by an adult when using this product and should use no more than a pea-sized amount. If over consumption occurs, please contact a qualified medical professional immediately.
    - Avoid sucking or swallowing.
    - For oral hygiene purposes only.
    - If any side effects occur, please contact a qualified medical or dental professional immediately.



  • DOSAGE & ADMINISTRATION

    for dental use only


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    AQUAPICK WHITENING BUBBLEPICK  
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58399-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.001 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SAGE (UNII: 065C5D077J)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58399-1001-150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/02/2013
    Labeler - Aquapick Co., Ltd (688444236)
    Registrant - Aquapick Co., Ltd (688444236)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co. Ltd687846360manufacture(58399-1001)
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