2080 DENTISTRY NIGHT FRESH- dental type silica (silicon dioxide), zinc citrate, trihydrate, cetylpyridinium chloride, dipotassium glycyrrhizinate paste, dentifrice 
Aekyung Industrial 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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Drug Facts

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

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 the reach of children under 6 years of age

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

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.

- Removes bad breath

- Maintains oral health

Directions: Apply suitable amount of toothpaste to toothbrush

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

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

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

Manufacturer: Aekyung Co., Ltd

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

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

Box Label

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)

Revised: 2/2017
Document Id: 5b63c38f-b307-40f1-8d85-b0365a4de261
Set id: e2263f8a-c354-4a3d-8e06-f1f3bbdef79f
Version: 2
Effective Time: 20170203
 
Aekyung Industrial Co., Ltd.