Label: CLINPLANT- edta disodium salt gel, dentifrice
- NDC Code(s): 47649-0002-1
- Packager: Nibec Co., Ltd
- 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.
Updated July 19, 2018
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
INDICATIONS & USAGE
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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
edta disodium salt gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47649-0002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EDETATE DISODIUM (UNII: 7FLD91C86K) (EDETIC ACID - UNII:9G34HU7RV0) EDETATE DISODIUM 24 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) WATER (UNII: 059QF0KO0R) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47649-0002-1 4 g in 1 BOX; Type 0: Not a Combination Product 06/25/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/20/2018 Labeler - Nibec Co., Ltd (687796909) Registrant - Nibec Co., Ltd (687796909) Establishment Name Address ID/FEI Business Operations Nibec Co., Ltd 687796909 manufacture(47649-0002)