Label: 2080 DENTISTRY NIGHT REPAIR (dental type silica- silicon dioxide, calcium glycerophosphate, cetylpyridinium chloride, dipotassium glycyrrhizinate 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 February 3, 2017

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  • 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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