CLINPLANT (EDTA DISODIUM SALT) GEL, DENTIFRICE [NIBEC CO., LTD]

CLINPLANT (EDTA DISODIUM SALT) GEL, DENTIFRICE [NIBEC CO., LTD]
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NDC 47649-0002-1
Set ID 6f9448b6-3bec-2fc3-e053-2a91aa0a2fd7
Category HUMAN OTC DRUG LABEL
Packager Nibec Co., Ltd
Generic Name
Product Class Anti-coagulant
Product Number
Application Number
  • 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)

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