2080 DENTISTRY NIGHT REPAIR- dental type silica (silicon dioxide), calcium glycerophosphate, 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.

----------

Drug Facts

Active Ingredients​Purpose
 Dental-Type Silica 15%Anticavity
 Calcium Glycerophosphate 0.13%Antisensitivity
 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.

- Prevents and reduces tooth pain

- Maintains oral hygiene

- Removes bad breath

- Prevents dental caries

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), 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

Box Label

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)

Revised: 2/2017
Document Id: e0028b76-0496-4f8f-95ba-817bfc9164c1
Set id: dde82f7d-e6bb-49af-a4c8-979821b7436f
Version: 1
Effective Time: 20170203
 
Aekyung Industrial Co., Ltd.