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Drug Facts
Manufacturer: Aekyung Co., Ltd
1547-9 Chungui-ro, Jeongsan-myeon, Cheongyanggun, Chungcheongnam-do, Korea
2080 Dentistry Night Fresh
FDA Label NDC 67225-0009
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 Fresh (NDC 67225-0009). 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 |
| 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.
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
- Removes bad breath
- Maintains oral health
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), 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
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