2080 DENTISTRY NIGHT REPAIR (DENTAL TYPE SILICA (SILICON DIOXIDE), CALCIUM GLYCEROPHOSPHATE, CETYLPYRIDINIUM CHLORIDE, DIPOTASSIUM GLYCYRRHIZINATE) PASTE, DENTIFRICE [AEKYUNG INDUSTRIAL CO.,

2080 DENTISTRY NIGHT REPAIR (DENTAL TYPE SILICA (SILICON DIOXIDE), CALCIUM GLYCEROPHOSPHATE, CETYLPYRIDINIUM CHLORIDE, DIPOTASSIUM GLYCYRRHIZINATE) PASTE, DENTIFRICE [AEKYUNG INDUSTRIAL CO.,
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NDC 67225-0010-1
Set ID dde82f7d-e6bb-49af-a4c8-979821b7436f
Category HUMAN OTC DRUG LABEL
Packager Aekyung Industrial Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART332
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients​Purpose
     Dental-Type Silica 15%Anticavity
     Calcium Glycerophosphate 0.13%Antisensitivity
     Cetylpyridinium Chloride 0.05%Antigingivitis
     Dipotassium Glycyrrhizinate 0.01%Antigingivitis

  • WARNINGS

    Be careful not to swallow.  Rinse your mouth thoroughly after use.  Consult a doctor or dentist if gum problems occur after using this toothpaste.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 6 years of age

  • STOP USE

    Stop using this product and consult your dentist if irritation to gums, teeth, or oral mucosa occurs

  • DOSAGE & ADMINISTRATION

    Do not swallow.  Rinse mouth with water after brushing.

    Children under 6 years:

        - To minimize swallowing, use a pea-sized amount.  Supervise brushing until good habits are established.

        - If swallowed more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    - Prevents and reduces tooth pain

    - Maintains oral hygiene

    - Removes bad breath

    - Prevents dental caries

  • INSTRUCTIONS FOR USE

    Directions: Apply suitable amount of toothpaste to toothbrush

  • DO NOT USE

    Do not use for purpose other than brushing teeth.  Rinse with running water in the event that the toothpaste gets in the eye and consult a doctor for adverse reactions

  • STORAGE AND HANDLING

    Store in a sealed container at room temperature {1~30°C}

  • QUESTIONS

    Customer Center: 080-024-1357 (Nationwide Toll-Free)

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

    www.aekyung.co.kr

  • SPL UNCLASSIFIED SECTION

    Manufacturer: Aekyung Co., Ltd

    1547-9 Chungui-ro, Jeongsan-myeon, Cheongyanggun, Chungcheongnam-do, Korea

  • INACTIVE INGREDIENT

    Inactive Ingredients: Liquid Sorbitol (Non-crystalizing), Sodium N-Cocoyl-N-Methyl Taurate Solution, Polyethylene Glycol 1500, Cocamidopropyl Betain, Gellan Gum, Flavor, Calcium Chloride, Carboxymethylcellulose Sodium, Titanium Dioxide, Saccharin Sodium Hydrate, Xanthan Gum, Carrageenan, Purified Water

  • PRINCIPAL DISPLAY PANEL

    Box Label

  • INGREDIENTS AND APPEARANCE
    2080 DENTISTRY NIGHT REPAIR 
    dental type silica (silicon dioxide), calcium glycerophosphate, cetylpyridinium chloride, dipotassium glycyrrhizinate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-0010
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67225-0010-11 in 1 CARTON02/03/2017
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/03/2017
    Labeler - Aekyung Industrial Co., Ltd. (687995647)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aekyung Ind. Co., Ltd._Chungyang Factory690511126manufacture(67225-0010)

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