Label: DENTAL CLINIC 2080 K CITRUS COOL MINT- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 21, 2014

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  • 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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)
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