FDA Label for 2080 Dentistry Night Repair

View Indications, Usage & Precautions

2080 Dentistry Night Repair Product Label

The following document was submitted to the FDA by the labeler of this product Aekyung Industrial Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

Manufacturer: Aekyung Co., Ltd

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


Otc - Active Ingredient




Otc - Purpose



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.


Otc - Keep Out Of Reach Of Children



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


Otc - 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


Otc - 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}


Otc - 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


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


Package Label.Principal Display Panel




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