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Drug Facts
Manufacturer: Aekyung Co., Ltd
1547-9 Chungui-ro, Jeongsan-myeon, Cheongyanggun, Chungcheongnam-do, Korea
2080 Dentistry Night Repair
FDA Label NDC 67225-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aekyung Industrial Co., Ltd. for the product 2080 Dentistry Night Repair (NDC 67225-0010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, otc - stop use, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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