DENTAL CLINIC 2080 K CITRUS COOL MINT- sodium fluoride paste, dentifrice 
Aekyung Ind. Co., Ltd.

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.

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Dental Clinic 2080 K Toothpaste Citrus Cool Mint

Dental Clinic 2080 K Toothpaste Citrus Cool Mint

Active Ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

do not swallow.

supervise children as necessary until capable of using without supervision.

Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.

Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Liquid Sorbitol, Dental-Type Silica, Sodium Chloride, Sodium Lauryl sulphate, Sodium carboxymethylcellulose, Panthenol, Polyethylene Glycol 1500, Saccharin Sodium Hydrate, Phosphoric acid, Water

Dental Clinic 2080 Gingivalis Project K

Gingivitis-causing Bacteria

99% Inhibits

in-vitro test Results

Tested by Dental School Clinic

Dental Clinic 2080 K Toothpaste Citrus Cool Mint

OTC Drug

Customer Center:060-024-1357 (Nationwide Toll-Free)

We accept returns in compliance with the Consumer Protection Act of Fair Trade Commission.

AEKYUNG

MADE IN KOREA

www.aekyung.co.kr

Net Weight: 100g

Dental Clinic 2080 K Toothpaste Citrus Cool Mint, 100g (67225-0003-1)

CitrusCoolMint
DENTAL CLINIC 2080 K CITRUS COOL MINT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-0003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYGLUCOSE SORBITOL CARBOXYMETHYL ETHER (UNII: Y8P5S7CF2S)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PANTHENOL (UNII: WV9CM0O67Z)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCITRUS (Citrus Cool Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67225-0003-11 in 1 PACKAGE
1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/16/2014
Labeler - Aekyung Ind. Co., Ltd. (690511126)
Registrant - Aekyung Ind. Co., Ltd. (690511126)
Establishment
NameAddressID/FEIBusiness Operations
Aekyung Ind. Co., Ltd.690511126manufacture(67225-0003)

Revised: 5/2014
Document Id: 46dbc0b3-59e7-4459-8061-f4c275da7f76
Set id: 22330f78-f719-4109-b0f9-c953fb5665ff
Version: 2
Effective Time: 20140521
 
Aekyung Ind. Co., Ltd.