Label: CLINPLANT- edta disodium salt gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 19, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    EDTA disodium salt(EDTA-2Na-2H2O)

  • INACTIVE INGREDIENT

    Cetylpyridinium Chloride (CPC), Carboxylmethylcellulose Sodium(Na-CMC), Triton X-100, Sodium bicarbonate, Purified water

  • PURPOSE

    NIBEC Clinplant is convenient gel type fomlulation, patented by NIBEC, for prevention of plaque accumulation and gingival inflammation.NIBEC Cinplant can remove dental plaque, inhibit the growth of periodontal pathogen, and alleviate gingival inflammation

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    <with tip>
    1. Remove the plastic cap of the syringe.
    2. Carefully install the supplied application tip (shaped like needle).
    3. Apply to appropriate oral area such as interproximal space and area surrounding dental implants.
    4. Gently rub for 1 -2 minutes and rinse the applied area with saline.


    < with microbrush >
    1. Small quantity of Clinplant gel is placed on microbrush.
    2 Apply to the lntl!rproxlmal area (of tooth or Implant) with a mlcrobrush.
    3.Gentlyrubfor 1-2 minutes and rinse the applied area with sallne.
    • For better results, please instruct your patients to regularly visit the dental clinic and also to use Clinplant Floss (CF-1) at home everyday

  • WARNINGS

    1. The proximal brush is washed well and dried after using.
    2. Small amount of Clinplant is enough for interproximal brush.

    3. Do not swallow.
    4. Do not use in children under the age of 6.

  • DOSAGE & ADMINISTRATION

    for dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CLINPLANT 
    edta disodium salt gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47649-0002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) (EDETIC ACID - UNII:9G34HU7RV0) EDETATE DISODIUM24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    WATER (UNII: 059QF0KO0R)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47649-0002-14 g in 1 BOX; Type 0: Not a Combination Product06/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/20/2018
    Labeler - Nibec Co., Ltd (687796909)
    Registrant - Nibec Co., Ltd (687796909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nibec Co., Ltd687796909manufacture(47649-0002)