CLINPLANT- edta disodium salt gel, dentifrice

Clinplant by

Drug Labeling and Warnings

Clinplant by is a Otc medication manufactured, distributed, or labeled by Nibec Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CLINPLANT 
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)