Label: 2080 DENTISTRY NIGHT FRESH (dental type silica- silicon dioxide, zinc citrate, trihydrate, 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
     Zinc Citrate, trihydrate 0.5%Anti Oral Malodor
     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

    - Removes bad breath

    - Maintains oral health

  • 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), Glycerin, Polyethylene Glycol 1500, Sodium Alginate, Trisodium Citrate, Saccharin Sodium Hydrate, Cocamidopropyl Betain, Sodium Lauryl Sulfate, Sodium N-Cocoyl-N-Methyl Taurate Solution, Titanium Dioxide, Thymus Vulgaris (Thyme) Leaf Extract, Cymbopogon Citratus Extract, Pelargonium Graveolens Extract, Cinnamonium Zeylanicum Bark Extract, Foenlculum Vulgare (Fennel) Seed Extract, Rosemarinus Officinalis (Rosemary) Leaf Extract, Eugenia Caryphyllus (Clove) Flower Extract, Purified Water

  • PRINCIPAL DISPLAY PANEL

    Box Label

  • INGREDIENTS AND APPEARANCE
    2080 DENTISTRY NIGHT FRESH 
    dental type silica (silicon dioxide), zinc citrate, trihydrate, cetylpyridinium chloride, dipotassium glycyrrhizinate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-0009
    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)  
    ZINC CITRATE TRIHYDRATE (UNII: GNM26GAX7R)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    CYMBOPOGON CITRATUS WHOLE (UNII: 6AE8LT94NG)  
    PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    FENNEL SEED (UNII: G3QC02NIE6)  
    ROSEMARY (UNII: IJ67X351P9)  
    CLOVE (UNII: K48IKT5321)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67225-0009-11 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(67225-0009)
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